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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00102414

Enrollment

356

Registered

2005-01-31

Start date

1999-09-30

Completion date

2004-11-30

Last updated

2006-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

Ovarian cancer, Recurrence or progression, Gemcitabine plus Carboplatin vs Carboplatin

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.

Interventions

DRUGGemcitabine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to progressive disease	—

Secondary

Measure	Time frame
Response rate	—
Duration of response	—
Survival time	—
Toxicity	—
Quality of Life	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026