Brief Title
Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer
Official Title
A Multi-National Randomized Phase-III GCIG Intergroup-Study Comparing 1st-line Chemotherapy With Gemcitabine/Paclitaxel/Carboplatin vs Paclitaxel/Carboplatin In Previously Untreated Patients With Epithelial Ovarian Cancer FIGO Stages I-IV
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
yet known whether carboplatin and paclitaxel combined with gemcitabine is more effective than
carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube cancer.
PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel combined with
gemcitabine to see how well it works compared to paclitaxel and carboplatin alone in treating
patients who have undergone surgery for ovarian epithelial or fallopian tube cancer.
Detailed Description
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Overall Survival
Secondary Outcome
Progression Free Survival
Condition
Fallopian Tube Cancer
Intervention
TCG
Study Arms / Comparison Groups
TCG
Description: Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, Gemcitabine 800 mg/m2 day 1 + 8, q 21 days / 6 - 10 courses
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
1742
Start Date
August 2002
Completion Date
January 2011
Primary Completion Date
July 2009
Eligibility 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Andreas du Bois, MD, PhD, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT00052468
Organization ID
CDR0000258429
Secondary IDs
AGO-OVAR9
Responsible Party
Sponsor
Study Sponsor
AGO Study Group
Collaborators
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Study Sponsor
Andreas du Bois, MD, PhD, Study Chair, Dr. Horst-Schmidt-Kliniken
Verification Date
June 2014