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
18 Years
N/A
Female
Fallopian Tube Cancer, Ovarian Cancer
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
OBJECTIVES:
- 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.
- 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
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
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 6 months
Hematopoietic
- 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
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
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
Type of Study:
Interventional
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
Authority:
United States: Federal Government
Study ID:
CDR0000258429
NCT ID:
NCT00052468
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
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