Status:
COMPLETED
Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Ovarian Cancer
Lead Sponsor:
AGO Study Group
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to compare the time to progressive disease in patients treated with gemcitabine plus carboplatin versus carboplatin monotherapy. Patients will have advanced epit...
Detailed Description
Carboplatin is commonly used for the treatment of ovarian cancer in first- and second-line therapy. The efficacy of gemcitabine in ovarian carcinoma was researched in various Phase 2 studies.
Eligibility Criteria
Inclusion
- Histologically proven ovarian cancer with evidence of recurrence or progression
- Failed first-line platinum containing therapy after 6 months of treatment discontinuation
- Documented lesion as evidenced by appropriate computerized tomography (CT), magnetic resonance imaging (MRI) scan, chest x-ray, or ultrasound.
- Previous hormonal therapy or radiotherapy must be terminated at least 3 weeks before study drug administration
- Adequate bone marrow reserve: neutrophils ≥ 1.5 x 10\^9/L and platelets ≥ 100 x 10\^9/L
Exclusion
- Receiving concomitant cytotoxic or other antineoplastic treatment. Hormone replacement therapy is allowed, as are steroid antiemetics
- Clinical evidence of central nervous system metastases
- Active infection
- Cannot adequately be followed up for the duration of the study
- A second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
- Use of any investigational agent in the 3 weeks prior to inclusion
- Serious concomitant systematic disorders incompatible with the study
- Received more than one previous chemotherapy regimen or had prior gemcitabine treatment
- Patients with tumor of borderline malignancy
- Patients with estimated GFR ≤ 50 mL/min
Key Trial Info
Start Date :
September 1 1999
Trial Type :
INTERVENTIONAL
End Date :
November 1 2004
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT00102414
Start Date
September 1 1999
End Date
November 1 2004
Last Update
November 14 2006
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