Brief Title
Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer
Official Title
Phase III Multicenter Study in Epithelial Ovarian Carcinoma FIGO Stage IIB-IV Comparing Treatment With Paclitaxel and Carboplatin to Paclitaxel and Carboplatin Sequentially Followed by Topotecan
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 if paclitaxel plus carboplatin is more effective with or without topotecan for
ovarian epithelial cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel plus
carboplatin with or without topotecan in treating patients who have stage IIB, stage III, or
stage IV ovarian epithelial cancer.
Detailed Description
OBJECTIVES: I. Compare survival of patients with stage IIB, III, or IV ovarian epithelial
carcinoma after receiving treatment with paclitaxel and carboplatin with or without
topotecan. II. Compare progression-free survival of these patients after receiving these
treatment regimens. III. Compare the response rate and response duration in these patients
treated with these regimens. IV. Determine the toxic effects of the combination of
paclitaxel, carboplatin, and topotecan in these patients. V. Compare the toxic effects of
these treatment regimens in these patients. VI. Compare quality of life of these patients
treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center and stage (stage IIB and stage III optimally debulked to no greater than
1 cm residual tumor vs stage IV regardless of residual tumor or residual tumor greater than 1
cm). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel
IV over 3 hours and carboplatin IV over 0.5-1 hour on day 1 and topotecan IV over 0.5 hour on
days 1-5. Treatment repeats every 21 days for 6 courses (topotecan is administered for 4
courses only). Arm II: Patients receive paclitaxel and carboplatin as in arm I. Treatment
repeats every 21 days for 6 courses. Quality of life is assessed before courses 1, 3, and 5
and at 3 weeks and 3 months after completion of treatment in both treatment arms; before
courses 1 and 3 of topotecan in arm I; and at 6 months after completion of treatment in arm
II. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 914 patients (457 per treatment arm) will be accrued for this
study over 2 years.
Study Phase
Phase 3
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
carboplatin
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
Start Date
December 1999
Completion Date
August 2006
Primary Completion Date
August 2006
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage IIB, III, or IV ovarian epithelial
carcinoma, fallopian tube, or extraovarian papillary serous carcinoma extending to the
ovary No mixed epithelial/non-epithelial tumors (e.g., mixed Mullerian tumors) No tumors of
low malignant potential (e.g., borderline tumors) No symptomatic brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 70-100%
Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times
the upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN Renal:
Creatinine no greater than 1.25 times ULN Estimated glomerular filtration rate at least 60
mL/min Cardiovascular: No history of congestive heart failure (even if medically
controlled) No New York Heart Association class III or IV heart disease No myocardial
infarction within the past 6 months No history of atrial or ventricular arrhythmias Other:
No motor or sensory neurologic pathology or symptoms greater than grade 1 No active
infection or other serious medical condition that would preclude study No prior allergy to
drug containing Cremophor EL No dementia or significantly altered mental state that would
preclude informed consent No complete bowel obstruction No other prior malignancy except
curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not
pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No concurrent WBC
transfusions Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine
therapy: No concurrent hormonal therapy Radiotherapy: No prior radiotherapy No concurrent
radiotherapy Surgery: No more than 6 weeks since prior definitive laparotomy and recovered
Other: No other concurrent antineoplastic agents No other concurrent investigational drugs
Gender
Female
Ages
18 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
Jacobus Pfisterer, MD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT00006454
Organization ID
CDR0000067994
Secondary IDs
AGOSG-OVAR-7
Responsible Party
Sponsor
Study Sponsor
AGO Study Group
Study Sponsor
Jacobus Pfisterer, MD, Study Chair, University of Schleswig-Holstein
Verification Date
December 2015