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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

Phase 3
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer

Thank you

Trial Information

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


- Compare overall survival in patients with stage I-IV ovarian epithelial or fallopian
tube cancer treated with adjuvant carboplatin and paclitaxel with or without

- Compare response rates, progression-free survival, and duration of response in patients
treated with these regimens.

- Compare toxic effects of these regimens in these patients.

- Compare quality of life of patients treated with these regimens.

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.

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

Inclusion Criteria


- 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



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 6 months


- WBC at least 3,000/mm^3 OR

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin greater than 10 mg/dL


- Bilirubin no greater than 2 times upper limit of normal


- Glomerular filtration rate at least 50 mL/min


- 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


- 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

- No concurrent severe active infection

- Geographically accessible for treatment and follow-up


Biologic therapy

- No concurrent immunotherapy


- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent hormonal therapy except:

- Hormone replacement therapy

- Antiemetic steroids


- No prior radiotherapy

- No concurrent radiotherapy


- See Disease Characteristics

- Recovered from prior surgery


- No other concurrent antineoplastic agents

- No other concurrent investigational drugs

- No other concurrent clinical trial enrollment

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Andreas du Bois, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Dr. Horst-Schmidt-Kliniken


United States: Federal Government

Study ID:




Start Date:

August 2002

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • fallopian tube cancer
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms