S9701 Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission

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

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