S9912 Combination Chemo in Stage III Ovarian Cancer,

Brief Title

S9912 Combination Chemo in Stage III Ovarian Cancer,

Official Title

Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian Cancer

Brief Summary

      RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
      dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, cisplatin, and
      liposomal doxorubicin in treating women who have undergone surgery for stage III ovarian
      cancer, fallopian tube cancer, or primary peritoneal cancer.

Detailed Description

      OBJECTIVES:

        -  Determine the efficacy of intraperitoneal (IP) cisplatin, IP and IV paclitaxel, and IV
           doxorubicin HCl liposome, in terms of progression-free survival and overall survival, in
           patients with optimally debulked stage III ovarian epithelial, fallopian tube, or
           primary peritoneal cancer.

        -  Determine the feasibility of and toxic effects associated with this regimen in these
           patients.

      OUTLINE: This is a multicenter study.

      Patients receive paclitaxel IV over 3 hours on day 1, intraperitoneal (IP) cisplatin over
      30-60 minutes on day 2, IP paclitaxel over 30-60 minutes on day 8, and doxorubicin HCl
      liposome IV over 1 hour on day 8. Patients not able to tolerate IP infusion receive
      paclitaxel IV and cisplatin IV on day 1 only. Treatment repeats every 28 days for 6 courses
      in the absence of disease progression or unacceptable toxicity.

      Patients are followed every 6 months for 2 years and then annually thereafter.

      PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Progression-free Survival

Secondary Outcome

 Adverse Events

Condition

Fallopian Tube Cancer

Intervention

cisplatin

Study Arms / Comparison Groups

 Paclitaxel/cisplatin/Liposomal Doxorubicin

Description:  paclitaxel, cisplatin and liposomal doxorubicin

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

September 1999

Completion Date

February 2008

Primary Completion Date

February 2008

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed stage III ovarian epithelial, fallopian tube, or primary
             peritoneal carcinoma

               -  Tumor involves one or both ovaries with microscopically confirmed peritoneal
                  metastasis outside the pelvis and/or regional lymph node metastasis

               -  No tumors of borderline or low malignant potential only

               -  Mixed Mullerian tumors allowed

          -  Must have optimal disease defined as no residual lesions after resection or residual
             disease such that no single lesion measures greater than 1 cm in diameter

          -  Must have undergone staging exploratory laparotomy with tumor debulking within the
             past 70 days

        PATIENT CHARACTERISTICS:

        Age:

          -  Not specified

        Performance status:

          -  SWOG 0-1

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Granulocyte count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic:

          -  Bilirubin ≤ 2 times upper limit of normal (ULN)

          -  SGOT or SGPT ≤ 2 times ULN

        Renal:

          -  Creatinine clearance ≥ 50 mL/min

        Cardiovascular:

          -  No congestive heart failure

          -  No cardiac arrhythmia

          -  No myocardial infarction or unstable angina within the past 6 months

          -  Patients with a history of myocardial disease must not have ischemia or pathologic
             arrhythmias and must have an ejection fraction > 50% by MUGA

        Other:

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No active or uncontrolled infection

          -  No concurrent fever

          -  No grade 2 or greater sensory neuropathy

          -  No severe gastrointestinal symptoms (i.e., partial obstruction) and/or bleeding,
             diarrhea, or abdominal tenderness suggestive of peritoneal irritation or infection

          -  No erythema or tenderness of abdominal incision or port site suggestive of underlying
             infection

          -  No other malignancy within the past five years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior immunotherapy for ovarian cancer

        Chemotherapy:

          -  No prior chemotherapy for ovarian cancer

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  No prior pelvic radiotherapy for ovarian cancer

        Surgery:

          -  See Disease Characteristics

          -  Recovered from all reversible surgery-related toxic effects

        Other:

          -  No other concurrent antitumor treatment

          -  No concurrent antibiotics for infection of undetermined etiology

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Harriet O. Smith, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00003896

Organization ID

CDR0000067066

Secondary IDs

S9912

Responsible Party

Sponsor

Study Sponsor

Southwest Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Harriet O. Smith, MD, Study Chair, University of New Mexico Cancer Center

Verification Date

January 2013