Clinical trial NCT00102414: Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Ovarian Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Keywords: Ovarian cancer
Recurrence or progression
Gemcitabine plus Carboplatin vs Carboplatin
Lead sponsor: AGO Study Group
Sponsor class: OTHER
First posted: 2005-01-31
Enrollment: 356
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 epithelial ovarian cancer and have failed first-line platinum-containing therapy 6 months after treatment discontinuation.

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 Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Time to progressive disease
Secondary outcomes:
measure: Response rate
measure: Duration of response
measure: Survival time
measure: Toxicity
measure: Quality of Life
Other outcomes:
Locations:
Study officials:
affiliation: AGO Study Group
name: Jacobus Pfisterer, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pfisterer J, Plante M, Vergote I, du Bois A, Hirte H, Lacave AJ, Wagner U, Stahle A, Stuart G, Kimmig R, Olbricht S, Le T, Emerich J, Kuhn W, Bentley J, Jackisch C, Luck HJ, Rochon J, Zimmermann AH, Eisenhauer E; AGO-OVAR; NCIC CTG; EORTC GCG. Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG. J Clin Oncol. 2006 Oct 10;24(29):4699-707. doi: 10.1200/JCO.2006.06.0913. Epub 2006 Sep 11.