Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	Other	AGO-OVAR-9 NORDIC-AGO-OVAR-9, GERCOR-AGO-OVAR-9, EU-20241, NCT00052468

Objectives

1. Compare overall survival in patients with stage I-IV ovarian epithelial or fallopian tube cancer treated with adjuvant carboplatin and paclitaxel with or without gemcitabine.
2. Compare response rates, progression-free survival, and duration of response in patients treated with these regimens.
3. Compare toxic effects of these regimens in these patients.
4. Compare quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed diagnosis of one of the following:
  • Ovarian epithelial cancer
    • FIGO stage IA/B G3, IC-IV
  • Fallopian tube cancer
  • Extra-ovarian papillary serous tumor



• The following are ineligible:
  • Low malignant-potential ovarian tumors (borderline tumors)
  • Non-epithelial ovarian tumors
  • Mixed Mullerian tumors



• Must have had definitive surgery within the past 6 weeks



• No symptomatic brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent immunotherapy

Chemotherapy

• No prior chemotherapy
• No other concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy except:
  • Hormone replacement therapy
  • Antiemetic steroids

Radiotherapy

• No prior radiotherapy
• No concurrent radiotherapy

Surgery

• See Disease Characteristics
• Recovered from prior surgery

Other

• No other concurrent antineoplastic agents
• No other concurrent investigational drugs
• No other concurrent clinical trial enrollment

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Hematopoietic

• WBC at least 3,000/mm³

  OR

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin greater than 10 mg/dL

Hepatic

• Bilirubin no greater than 2 times upper limit of normal

Renal

• Glomerular filtration rate at least 50 mL/min

Cardiovascular

• No congestive heart failure
• No myocardial infarction within the past 6 months
• No New York Heart Association class III or IV heart disease
• No prior atrial or ventricular arrhythmias

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior seizures or central nervous system disorder
• No prior severe hypersensitivity reaction to products containing Cremophor EL (e.g., cyclosporine or vitamin K)
• No known hypersensitivity to compounds chemically related to carboplatin, gemcitabine, or paclitaxel
• No preexisting motor or sensory neuropathy greater than grade 1
• No other malignancy within the past 5 years except:
  • Malignancies cured by surgery alone
  • Carcinoma in situ of the cervix
  • Adequately treated basal cell skin cancer
• No complete bowel obstruction
• No other concurrent severe medical condition that would preclude study participation
• No dementia or significantly altered mental status that would preclude study participation
• No concurrent severe active infection
• Geographically accessible for treatment and follow-up

Expected Enrollment

A total of 1,716 patients (858 per treatment arm) will be accrued for this study within 2 years.

Outline

This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to FIGO stage (I-IIA vs IIB-IIIC and tumor no greater than 10 mm vs IIB-IIIC and tumor greater than 10 mm or IV), plan for interval surgical debulking (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive carboplatin IV over 30-60 minutes and paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8.



• Arm II: Patients receive carboplatin and paclitaxel as in arm I.

Treatment in both arms repeats every 21 days for 6 to 10 courses in the absence of disease progression or unacceptable toxicity.

Some patients undergo interval debulking surgery.

Quality of life is assessed at baseline, after courses 3 and 6, and then at 3, 6, and 12 months after completion of study.

Patients are followed every 3 months for 2 years, every 6 months for up to 5 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

AGO Ovarian Cancer Study Group

Andreas du Bois, MD, PhD, Protocol chair		Ph: 49-611-43-23-77

Nordic Society for Gynaecologic Oncology

J. Herrstedt, Protocol chair		Ph: 45-44-883-500

GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie

E. Pujade-Lauraine, MD, PhD, Protocol chair		Ph: 33-1-42-34-82-22 Email: epujade@arcagy.org

Registry Information
Official Title		A Multi-National Randomized Phase III GCIG Intergroup Study Comparing 1st Line Chemotherapy With Gemcitabine, Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Previously Untreated Patients With Epithelial Ovarian Cancer FIGO Stages I-IV
Trial Start Date		2002-08-12
Registered in ClinicalTrials.gov		NCT00052468
Date Submitted to PDQ		2002-09-30
Information Last Verified		2008-01-29

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