Gemcitabine Plus Cisplatin in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Is Recurrent or Has Not Responded to Platinum-based Chemotherapy

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating patients who have primary ovarian epithelial cancer or primary peritoneal cancer that is recurrent or has not responded to platinum-based chemotherapy.

Detailed Description
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OBJECTIVES: Determine the anti-tumor activity of gemcitabine and cisplatin in patients with recurrent or refractory platinum-resistant ovarian epithelial cancer or primary peritoneal carcinoma who have failed on higher priority treatment protocols. Determine the nature and degree of toxicity of this regimen in this patient population. Correlate ex vivo drug sensitivity and resistance with clinical response to this regimen in these patients. Correlate molecular markers of drug responsiveness and cellular apoptosis with ex vivo measures of drug resistance in these patients. OUTLINE: This is a multicenter study. Patients receive cisplatin IV over 1 hour followed by gemcitabine IV over 1 hour on days 1 and 8. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 5-14 months.

Official Title
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Evaluation of Gemcitabine and Cisplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer

Conditions
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Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed primary ovarian epithelial cancer or primary peritoneal carcinoma Recurrent or persistent disease Bidimensionally measurable disease by physical examination or medical imaging techniques Sonography is acceptable if lesions are clearly defined on initial examination and bidimensionally measurable Ascites and pleural effusions are not considered measurable disease Must not be eligible for a higher priority Gynecologic Oncology Group protocol Must have received one, and only one, prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease Initial treatment may include high-dose therapy, consolidation, or extended therapy administered after surgical or nonsurgical assessment If no prior paclitaxel, a second regimen containing paclitaxel allowed Platinum-resistant or refractory (i.e., treatment-free interval after platinum-based therapy of less than 6 months or progressed during platinum-based therapy) PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No active infection requiring antibiotics No other malignancy within the past 5 years except nonmelanoma skin cancer Sensory and motor neuropathy no greater than grade 1 PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic or immunologic therapy for ovarian or peritoneal cancer Chemotherapy: See Disease Characteristics No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens No prior gemcitabine At least 3 weeks since prior chemotherapy for ovarian or peritoneal cancer and recovered Endocrine therapy: At least 1 week since prior hormonal therapy for ovarian or peritoneal cancer Concurrent continuation of hormonal replacement therapy allowed Radiotherapy: At least 3 weeks since prior radiotherapy for ovarian or peritoneal cancer and recovered No prior radiotherapy to only site of measurable disease No prior radiotherapy to more than 25% of bone marrow Surgery: See Disease Characteristics At least 3 weeks since prior surgery for ovarian or peritoneal cancer and recovered Other: At least 3 weeks since other prior therapy for ovarian or peritoneal cancer No prior cancer treatment that would preclude study
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: gemcitabine hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian epithelial cancer, primary peritoneal cavity cancer