Brief Title
S9701 Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
Official Title
Phase III Randomized Trial of 12 Months vs. 3 Months of Paclitaxel in Patients With Advanced Ovarian Cancer Who Attain a Clinically Defined Complete Response (CR) Following Platinum/Paclitaxel-Based Chemotherapy
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. It is not yet known whether giving paclitaxel for a shorter
period of time is as effective as a standard course of treatment for advanced ovarian cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel given for 3
months with that of paclitaxel given for 12 months in treating patients who have stage III or
stage IV ovarian, fallopian tube, or primary peritoneal cancer.
Detailed Description
OBJECTIVES: I. Compare the effect of continuing paclitaxel for 12 months versus 3 months on
progression free survival and overall survival in women with advanced ovarian, fallopian
tube, or peritoneal cancer who attained complete remission on initial platinum (carboplatin
or cisplatin) and paclitaxel based chemotherapy. II. Assess the toxic effects associated with
prolonged paclitaxel administration in these patients.
OUTLINE: This is a randomized study. Patients are stratified by stage (optimal stage III vs
suboptimal stage III vs stage IV), prior treatments with paclitaxel (over at least 24 hours
vs over less than 24 hours), and age (65 and under vs over 65). Patients are randomized to
one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on day 1.
Treatment continues every 4 weeks for 3 courses in the absence of disease progression or
unacceptable toxicity. Arm II: Patients receive paclitaxel IV over 3 hours on day 1.
Treatment continues every 4 weeks for 12 courses in the absence of disease progression or
unacceptable toxicity. Patients are followed every 3 months until disease progression or 1
year from registration, then every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study
within 5 years.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
progression-free survival
Condition
Fallopian Tube Cancer
Intervention
paclitaxel
Study Arms / Comparison Groups
paclitaxel 3 cycles
Description: paclitaxel given for 3 cycles
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
308
Start Date
November 1997
Completion Date
November 2012
Primary Completion Date
June 2003
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed advanced ovarian epithelial, fallopian
tube, or primary peritoneal cancer Must have undergone an initial exploratory laparotomy
with tumor debulking AND Must be FIGO stage IIIA, IIIB, IIIC, or IV at the time of initial
laparotomy Must have attained a clinically defined complete remission (CR) following
treatment with platinum (cisplatin or carboplatin) and paclitaxel based combination
chemotherapy regimen by achieving the following: No evidence of cancer on physical
examination CA-125 no greater than 35 units/mL Creatinine no greater than 2.0 mg/dL OR
Creatinine clearance greater than 60 mL/min Bilirubin no greater than 2.0 mg/dL Negative
ascites No evidence of residual cancer on CT scan of the abdomen/pelvis or chest x-ray (or
chest CT scan, if performed) No symptoms felt to be secondary to persistent malignancy Must
have received a minimum of 5 and a maximum of 6 courses of chemotherapy prior to study Must
register for study within 21 to 56 days after prior chemotherapy Not concurrently
registered to SWOG-S9618, SWOG-S9619, SWOG-S9912, or SWOG-S0009 or front line treatment
phase III GOG trials
PATIENT CHARACTERISTICS: Age: Any age Performance status: SWOG 0-2 Life expectancy: Not
specified Hematopoietic: Granulocyte count at least 1,200/mm3 Platelet count at least
100,000/mm3 Hepatic: See Disease Characteristics Renal: See Disease Characteristics Other:
No prior malignancy within past 5 years except adequately treated basal cell or squamous
cell skin cancer, carcinoma in situ of the cervix, or incidental carcinoid
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent antitumor treatment No concurrent
immunotherapy Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy
Prior cisplatin allowed if initial dose at least 50 mg/m2 Prior carboplatin allowed if
initial dose at least 300 mg/m2 or AUC at least 4 No other concurrent chemotherapy
Endocrine therapy: No concurrent hormonal therapy Radiotherapy: No concurrent radiotherapy
No prior abdominal/pelvic irradiation Surgery: See Disease Characteristics No second look
laparotomy or laparoscopy
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Maurie Markman, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00003120
Organization ID
CDR0000065875
Secondary IDs
SWOG-S9701
Responsible Party
Sponsor
Study Sponsor
Southwest Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Maurie Markman, MD, Study Chair, The Cleveland Clinic
Verification Date
October 2014