Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Ovarian Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2004-11-30

Brief Summary

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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

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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.

Conditions

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Ovarian Cancer

Keywords

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Ovarian cancer Recurrence or progression Gemcitabine plus Carboplatin vs Carboplatin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gemcitabine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Jacobus Pfisterer, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

AGO Study Group

References

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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.

Reference Type RESULT

PMID: 16966687 (View on PubMed)

Other Identifiers

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AGO-OVAR 2.5

Identifier Type: -

Identifier Source: org_study_id