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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102414
• Other study ID #: AGO-OVAR 2.5
• Status: Completed
• Phase: Phase 3
• First received: January 29, 2005
• Last updated: November 13, 2006
• Start date: September 1999
• Est. completion date: November 2004

Study information

• Verified date: January 2005
• Source: AGO Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Gemcitabine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AGO Study Group

References & Publications (1)

Pfisterer J, Plante M, Vergote I, du Bois A, Hirte H, Lacave AJ, Wagner U, Stähle A, Stuart G, Kimmig R, Olbricht S, Le T, Emerich J, Kuhn W, Bentley J, Jackisch C, Lück HJ, Rochon J, Zimmermann AH, Eisenhauer E; AGO-OVAR; NCIC CTG; EORTC GCG. Gemcitabine — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progressive disease
Secondary	Response rate
Secondary	Duration of response
Secondary	Survival time
Secondary	Toxicity
Secondary	Quality of Life