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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Primary Peritoneal Cavity Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Evaluation of Gemcitabine and Cisplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer |
| Study Start Date: | January 2001 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 31 Study Locations| Study Chair: | Cheryl A. Brewer, MD | University of Illinois College of Medicine at Peoria |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00006028 History of Changes |
| Other Study ID Numbers: | CDR0000068041, GOG-0126L |
| Study First Received: | July 5, 2000 |
| Last Updated: | April 23, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent ovarian epithelial cancer primary peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Peritoneal Diseases Neoplasms by Histologic Type Gemcitabine Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 21, 2013