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

This study has been completed.
Sponsor:
Information provided by:
AGO Study Group
ClinicalTrials.gov Identifier:
NCT00102414
First received: January 29, 2005
Last updated: November 13, 2006
Last verified: January 2005
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: Gemcitabine
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AGO Study Group:

Primary Outcome Measures:
  • Time to progressive disease

Secondary Outcome Measures:
  • Response rate
  • Duration of response
  • Survival time
  • Toxicity
  • Quality of Life

Estimated Enrollment: 356
Study Start Date: September 1999
Estimated Study Completion Date: November 2004
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102414

Sponsors and Collaborators
AGO Study Group
Investigators
Principal Investigator: Jacobus Pfisterer, Prof. Dr. med. AGO Study Group
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00102414     History of Changes
Other Study ID Numbers: AGO-OVAR 2.5
Study First Received: January 29, 2005
Last Updated: November 13, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AGO Study Group:
Ovarian cancer
Recurrence or progression
Gemcitabine plus Carboplatin vs Carboplatin

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Gemcitabine
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 22, 2014