Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous 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. It is not yet known if carboplatin is more effective with or without gemcitabine for ovarian epithelial cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with or without gemcitabine in treating patients who have advanced ovarian epithelial cancer that has not responded to previous chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: carboplatin Drug: gemcitabine hydrochloride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy |
| Study Start Date: | September 1999 |
OBJECTIVES:
- Compare time to progression in patients with advanced ovarian epithelial carcinoma who failed prior first-line platinum-based therapy when treated with carboplatin with or without gemcitabine.
- Compare response rate, duration of response, and survival time of patients treated with these regimens.
- Compare the toxicity of these treatment regimens in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to progression-free time (6-12 months vs more than 12 months), type of prior first-line therapy, and bidimensionally measurable disease (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive carboplatin IV over 30-60 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8.
- Arm II: Patients receive carboplatin IV as in arm I. Treatment in both arms repeats every 3 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each subsequent chemotherapy course, and at 50 days after study.
Patients are followed at 50 days, every 2 months for 1 year, and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial carcinoma not amenable to curative surgery or radiotherapy
- Evidence of recurrence or progression 6 months after discontinuation of prior first-line platinum-containing regimen
- No tumor of borderline malignancy
- Evaluable disease outside previously irradiated area
- No CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Not specified
Renal:
- Glomerular filtration rate greater than 50 mL/min
Other:
- No concurrent active infection
- No other primary malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer
- No other concurrent serious systemic disorder
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No more than 1 prior platinum-based chemotherapy regimen
- No prior gemcitabine
- No other concurrent cytotoxic or antineoplastic treatment
Endocrine therapy:
- At least 3 weeks since prior hormonal therapy
- Concurrent hormone replacement therapy allowed
- Concurrent steroid antiemetics allowed
Radiotherapy:
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy (limited to the small pelvis)
- Concurrent palliative radiotherapy to nontarget lesions allowed
Surgery:
- See Disease Characteristics
Other:
- At least 3 weeks since other prior investigational agents
Contacts and Locations
Show 74 Study Locations| Study Chair: | Jacobus Pfisterer, MD | University of Schleswig-Holstein |
| Study Chair: | Angel J. Lacave, MD, PhD | Hospital Universitario Central de Asturias |
| Study Chair: | Marie Plante, MD | Centre Hospitalier Universitaire de Quebec |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00006453 History of Changes |
| Other Study ID Numbers: | CDR0000067993, AGOSG-OVAR-2.5, CAN-NCIC-OV15, EORTC-55005, EU-20064, NCI-V00-1601 |
| Study First Received: | November 6, 2000 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent ovarian epithelial cancer |
Additional relevant MeSH terms:
|
Ovarian 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 Neoplasms by Histologic Type Gemcitabine |
Carboplatin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 21, 2013