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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


Phase 3
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to progressive disease

Principal Investigator

Jacobus Pfisterer, Prof. Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

AGO Study Group

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AGO-OVAR 2.5

NCT ID:

NCT00102414

Start Date:

September 1999

Completion Date:

November 2004

Related Keywords:

  • Ovarian Cancer
  • Ovarian cancer
  • Recurrence or progression
  • Gemcitabine plus Carboplatin vs Carboplatin
  • Ovarian Neoplasms

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