13 studies in Ovarian cancer
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Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed Persistent or Recurrent Uterine or Ovarian Cancer
Scottsdale and Phoenix, AZ
Rochester, MN
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Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed Persistent or Recurrent Uterine or Ovarian Cancer
Location:
Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - To determine if treatment with paclitaxel and carboplatin does not result in an inferior death rate when compared to paclitaxel and ifosfamide in chemotherapy-naïve patients with newly diagnosed stage I-IV persistent or recurrent uterine or ovarian carcinosarcoma. Secondary - To determine if treatment with combination paclitaxel and carboplatin does not result in an inferior progression-free survival when compared to paclitaxel and ifosfamide. - To determine if acute toxicity, specifically physician-assessed neurotoxicity and infection, associated with combination paclitaxel and carboplatin is reduced compared to that of paclitaxel and ifosfamide. - To determine if treatment with combination paclitaxel and carboplatin is associated with superior patient reported quality of life and neurotoxicity scores compared to that of paclitaxel and ifosfamide. Tertiary - To bank formalin-fixed and paraffin-embedded tumor tissue and DNA extracted from whole blood specimens for future research. OUTLINE: Patients are stratified according to history of pelvic radiation (any vs none), disease status/stage at time of study registration (stage I-II [pelvic lymph nodes not surgically and pathologically assessed] vs FIGO stage I-II [pelvic lymph nodes surgically and pathologically assessed] vs FIGO stage III-IV vs recurrent), and measurable disease (any vs none). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. - Arm II: Patients receive paclitaxel as in arm I and ifosfamide IV over 1 hour on days 1-3. In both arms, treatment repeats every 21 days for 6-10 courses in the absence of disease progression or unacceptable toxicity. Archival formalin-fixed and paraffin-embedded tumor tissue samples and a pre-treatment blood sample are collected for further analysis. Patients also complete quality of life (FACT-G, FACT-En TOI) and neurotoxicity (FACT/GOG-Ntx subscale) assessments at baseline and at weeks 6, 15, and 26. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
NCT ID:
NCT00954174IRB Number:
09-006613Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
Jacksonville: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
Jacksonville, FL
Rochester, MN
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Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
Location:
Jacksonville, FL Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. To determine the response rate and progression-free survival at 6 months in patients with endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer. II. To determine the toxicity of the combination of temsirolimus and bevacizumab in patients with endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer. SECONDARY OBJECTIVES: I. To collect blood and tumor specimens from all patients entered on the trial for possible future analysis. OUTLINE: Patients receive temsirolimus intravenously (IV) on days 1, 8, 15, and 22, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 3 years.
NCT ID:
NCT01010126IRB Number:
08-005230Who can I contact for additional information about this study?
Rochester: Charles Erlichman 507-284-2511
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Jacksonville: Gerardo Colon-Otero 507-538-7623
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Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer
Jacksonville, FL
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Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer
Location:
Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of the combination of ABT-888 (veliparib) and weekly topotecan (topotecan hydrochloride) in adult patients with advanced solid tumors. (Phase I) II. To identify any anti-tumor activity of this treatment combination, as assessed by objective response in patients with advanced solid tumors. (Phase I) III. To assess the confirmed response rate for patients with epithelial ovarian cancer or primary peritoneal carcinoma treated with the combination of ABT-888 and weekly topotecan. IV. To assess the toxicity of the combination of ABT-888 and weekly topotecan in patients with epithelial ovarian cancer or primary peritoneal carcinoma. (Phase II) SECONDARY OBJECTIVES: I. To identify any pharmacokinetic interactions between ABT-888 and topotecan. (Phase I and II) II. Phase I MTD: to provide preliminary view as to difference in response and toxicity based on BRCA mutation status. (Phase I) III. To determine whether topotecan stimulates adenosine diphosphate (ADP)-ribose polymer formation in circulating peripheral blood mononuclear cells. (Phase I) IV. To determine whether ABT-888 inhibits basal or topotecan-stimulated ADP-ribose polymer formation. (Phase I) V. To determine whether topotecan stimulates ADP-ribose polymer formation in circulating tumor cells and whether ABT-888 modulates this. (Phase II) VI. To assess differences in the toxicity and/or efficacy of this regimen based on BRCA 1/2 mutational status. (Phase II) VII. To determine whether pretreatment tumor cell levels of topoisomerase I, poly ADP-ribose polymerase (PARP), BRCA1, BRCA2, XRCC1, tyrosyl-deoxyribonucleic acid (DNA) phosphodiesterase 1 (TDP1), P-glycoprotein or breast cancer resistance protein (BCRP) predict response to this regimen. (Phase II) VIII. To identify, in an exploratory manner, any transcriptional profiles that may predict response to this regimen. (Phase II) OUTLINE: This is a phase I, dose escalation study of veliparib and topotecan hydrochloride followed by a phase II study. Patients receive veliparib orally (PO) on days 1-3, 8-10, and 15-17 (veliparib is omitted on days 1-3 of course 2) and topotecan hydrochloride intravenously (IV) over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3 months (Phase I) or every 3 or 6 months for 5 years (Phase II).
NCT ID:
NCT01012817IRB Number:
09-000742Who can I contact for additional information about this study?
Rochester: Charles Erlichman 507-538-7623
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Scottsdale: Donald W. Northfelt 507-538-7623
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Study for Women With Platinum Resistant Ovarian Cancer Evaluating EC145 in Combination With Doxil® (PROCEED)
Jacksonville, FL
Scottsdale and Phoenix, AZ
Rochester, MN
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Study for Women With Platinum Resistant Ovarian Cancer Evaluating EC145 in Combination With Doxil® (PROCEED)
Location:
Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
This is a Phase 3 clinical trial to evaluate the efficacy and safety of the combination of EC145 and pegylated liposomal doxorubicin (PLD; available in the United States as Doxil® and outside the United States as Caelyx®) compared to PLD and placebo. Enrollment of 640 patients including approximately 500 that are folate receptor positive is planned. EC145 is a drug that is specifically designed to enter cancer cells via the folate vitamin receptor (FR) that is not generally found on normal cells. Experimental evidence shows that this target receptor is expressed on virtually all ovarian cancers. Early clinical evidence in a small number of Phase I participants, in a subset of participants in a completed single-arm Phase II study, and interim data from an ongoing randomized Phase 2 study (PRECEDENT) suggests that EC145 may have antitumor effect in women with platinum-resistant ovarian cancer and that EC145 alone and in combination with PLD is generally well-tolerated. This evidence suggests that EC145 may be useful as chemotherapy against platinum-resistant ovarian cancer. All participants will undergo imaging with the FR-targeting investigational diagnostic agent EC20 during the screening period to assess binding of the imaging agent EC20 to tumors. This non-invasive procedure will provide additional information on the utility of using EC20 imaging to identify subjects with the FR molecular "target" prior to treatment with EC145 therapy.
NCT ID:
NCT01170650IRB Number:
10-005707Who can I contact for additional information about this study?
Rochester: John Beranek 507-538-1424
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Scottsdale: Heidi Kogut 480-301-4976
Jacksonville: Carolyn Bieber 904-953-6824
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Intra-op Detection of Occult Ovarian Carcinoma Using a Folate-Alpha Receptor Specific Fluorescent Ligand
Rochester, MN
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Intra-op Detection of Occult Ovarian Carcinoma Using a Folate-Alpha Receptor Specific Fluorescent Ligand
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
Prognosis for many carcinomas, including ovarian carcinoma, is dependent on a complete surgical resection, also known as a R0 resection. At present, the ability to perform a complete resection with negative margins is limited by the surgeon's ability to palpate and visualize the tumor and its margins. Therefore, in order to reduce operative morbidity and costs while maintaining or improving surgical and oncologic outcomes, the investigators must develop technologies that improve visualization of the primary tumor and occult metastases, real time, during surgery. Recent research has demonstrated that the use of fluorescent probes that recognize cancer specific antigens can be used for this purpose when visualized using a prototype near-infrared multispectral imaging system. This investigation will determine if folate-FITC, a fluorescent probe that recognizes the folate receptor (present in > 90% of ovarian cancers) can facilitate surgical resection and detect tumor nodules not visible to the naked eye.
NCT ID:
NCT01511055IRB Number:
11-002980 -
A Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients With Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)
Scottsdale and Phoenix, AZ
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A Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients With Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)
Location:
Scottsdale and Phoenix, AZTrial status:
Open for EnrollmentWhy is this study being done?
The phase 1 dose escalation portion will establish the maximum tolerated dose (MTD) in patients with advanced solid tumors. Once the recommended phase 2 dose (RP2D) is established for both schedules, the phase 2 study will begin. Patients with relapsed/recurrent epithelial ovarian cancer will be randomized 1:1:1 to 3 treatment groups.
NCT ID:
NCT00889382IRB Number:
11-006840Who can I contact for additional information about this study?
- Mayo Clinic Cancer Center - Phone: 507-538-7623 - Research Volunteer Program - Phone: 1-800-664-4542 (toll-free) Email: clinicaltrials@mayo.edu - International Research - Phone: 507-284-8884 Email: intl.mcr@mayo.edu
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Chemotherapy Toxicity On Quality of Life in Older Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
Scottsdale and Phoenix, AZ
Rochester, MN
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Chemotherapy Toxicity On Quality of Life in Older Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
Location:
Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - To determine whether the score on Instrumental Activities of Daily Living (IADL) obtained at time of registration is associated with the ability of patients to complete four courses of chemotherapy without dose reduction or a more than 7-day delay. - To estimate by regimen the percentage of patients who are able to complete four courses of chemotherapy regardless of dose reductions and delays. - To compare actual and calculated carboplatin area under the curve (AUC) in this patient population. Secondary - To describe the percentage of patients who are entered after primary surgery versus those entered to receive primary or neoadjuvant chemotherapy, the percentage of patients who are treated with each allowed regimen, and the percentage of patients who eventually receive surgery in the primary chemotherapy group. - To determine whether the need for assistance with IADLs at time of registration is associated with choice of chemotherapy regimen (in both primary chemotherapy and primary surgery patients). - To explore whether age, baseline scores on the geriatric measures (functional status, nutritional status, or co-morbidity) and quality-of-life (QOL) are correlated with likelihood of completing four courses of chemotherapy without dose reduction or a more than 7-day delay. - To explore reasons for and timing of dose reductions and delays. - To describe toxicities, pre-/post-chemotherapy QOL, and pre-/post-chemotherapy scores on geriatric measures in this patient population. Tertiary - To explore potential relationships of carboplatin AUC, paclitaxel clearance, and paclitaxel time above a plasma concentration of 0.05 mcM to nadir neutrophil and platelet counts during course 1 of treatment. - To explore the association between baseline IADL and survival. - To explore the association between IADL and the functional well-being (FWB) subscale in the Functional Assessment of Cancer Therapy - Ovary (FACT-O). OUTLINE: Patients receive chemotherapy comprising carboplatin, paclitaxel, and filgrastim (regimen 1) or carboplatin alone (regimen 2) every 21 days for 4 courses according to their physicians and/or patients' choice. Patients may undergo surgery and/or further chemotherapy at the discretion of treating physician. Patients undergo blood sample collection at baseline and periodically during course 1 for pharmacokinetic studies. Patients' quality of life is assessed by the Functional Assessment of Cancer Therapy - Ovary (FACT-O), the Functional Assessment of Cancer Treatment - Neurotoxicity (FACT-Ntx subscale), the Instrumental Activities of Daily Living (IADL), and the Ability to Complete Social Activity questionnaires at baseline, prior to courses 1 and 3, and then 3-6 weeks after completion of course 4. Nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment are also assessed.
NCT ID:
NCT01366183IRB Number:
12-003141Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Cyclophosphamide and Vaccine Therapy in Treating Patients With Stage II-III Breast, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Rochester, MN
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Cyclophosphamide and Vaccine Therapy in Treating Patients With Stage II-III Breast, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. To assess the safety of administering a course of cyclophosphamide treatment followed by six subsequent monthly vaccinations with a peptide-based vaccine targeting folate receptor 1 (FR)-alpha (multi-epitope folate receptor alpha peptide vaccine). II. To assess the ability of this vaccination protocol to elicit an immune response as measured by activated FR-alpha-specific T lymphocytes or high-affinity antibodies. CORRELATIVE OBJECTIVES: I. To determine FR-alpha expression status of primary tumors when available as formalin-fixed, paraffin-embedded material and whether expression correlates with the ability to generate an immune response. II. To identify human lymphocyte antigen (HLA) class I binding peptides from FR-alpha that are recognized by lymphocytes from patients prior to and after vaccination. OUTLINE: Patients receive 100 mg cyclophosphamide orally daily for 1 week followed by a 1 week rest, and then another week of cyclophosphamide. Approximately 7-10 days after the last dose of cyclophosphamide, patients receive multi-epitope folate receptor alpha peptide vaccine intradermally (ID) on day 1. Vaccine treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3, 6, and 12 months.
NCT ID:
NCT01606241IRB Number:
11-000976Who can I contact for additional information about this study?
Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
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Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Rochester, MN
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Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. To estimate the progression-free survival (PFS) hazard ratio of the combination of weekly paclitaxel with vs without wild-type reovirus in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer. II. To determine the frequency and severity of adverse events associated with these regimens as assessed by CTCAE v4.0. SECONDARY OBJECTIVES: I. To estimate the progression-free survival and overall survival of patients treated with weekly paclitaxel alone and weekly paclitaxel with REOLYSIN. II. To estimate (and compare) the proportion of patients who respond to the regimen on each arm of the study (according to RECIST 1.1 with measurable patients and by CA-125 for those patients with detectible disease only). III. To characterize and compare progression-free survival and overall survival in patients with measurable disease (RECIST 1.1 criteria) and patients with detectable (non-measurable) disease. OUTLINE: This is a multicenter study. Patients are stratified according to their platinum-free interval (=< 182 days vs > 182 days) and measurable disease status (measurable vs non-measurable or detectable). Patients are randomized to 1 of 2 treatment arms ARM I: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. ARM II: Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5. In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
NCT ID:
NCT01199263IRB Number:
12-002613Who can I contact for additional information about this study?
Rochester: Jamie N. Bakkum-Gamez 507-538-7623
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Auranofin in Treating Patients With Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Rochester, MN
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Auranofin in Treating Patients With Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. To demonstrate the feasibility of conducting a 10-patient pilot study in asymptomatic ovarian cancer patients with cancer antigen (CA 125) elevation. SECONDARY OBJECTIVES: I. To explore whether oral gold therapy either stabilizes or lowers the CA 125 level and maintains patients in an asymptomatic state and to provide descriptive data on tumor response and duration of response. II. To acquire qualitative data on patients' perceptions of learning of CA 125 elevation. III. To explore whether immunohistochemical staining for PKC iota expression in resected tumor samples appears to be associated with clinical outcomes with auranofin. OUTLINE: Patients receive auranofin orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 2 years.
NCT ID:
NCT01747798IRB Number:
12-005248Who can I contact for additional information about this study?
Rochester: Mayo Clinic Clinical Trials Referral Office 507-538-7623
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