Docetaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer

Brief Title

Docetaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer

Official Title

Phase II Trial of Weekly Docetaxel (Taxotere®) and Carboplatin as Initial Chemotherapy for Women With Ovarian Cancer and Similar Malignancies

Brief Summary

      RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving docetaxel together with carboplatin
      works in treating patients with ovarian epithelial, fallopian tube, or peritoneal cavity
      cancer.

Detailed Description

OBJECTIVES:

Primary

- Determine whether weekly administration of docetaxel and carboplatin is safer than
conventional three-week chemotherapy courses, in terms of reducing the rate of
myelosuppression, in patients with stage IC-IV ovarian epithelial, fallopian tube, or
peritoneal cavity cancer.

Secondary

- Determine the quality of life of patients treated with this regimen.

- Determine the toxic effects of this regimen in these patients.

- Determine the efficacy of this regimen, in terms of clinical response rate, time to
disease progression, and findings at second-look surgery, in these patients.

OUTLINE: Patients receive docetaxel IV and carboplatin IV on days 1, 8, 15. Treatment repeats
every 28 days for up to 6 courses in the absence of disease progression or unacceptable
toxicity. Patients may then undergo optional second-look surgery. After completion of 6
courses of chemotherapy (and second-look surgery, if applicable), patients may receive
consolidation and/or salvage therapy at the discretion of the investigator.

Quality of life is assessed at baseline, before each treatment course, at the completion of
study treatment, and then annually for 2 years.

After completion of study treatment, patients are followed annually for 2 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2 years.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Reduction rate of myelosuppression

Secondary Outcome

 Quality of life as assessed by the Functional Assessment of Cancer Therapy -Ovarian (FACT-O) questionnaire

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

Estimated Enrollment

Start Date

December 2004

Completion Date

October 2006

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed ovarian epithelial, fallopian tube, or peritoneal cavity
             cancer

               -  Stage IC-IV disease

               -  No borderline or low malignant potential tumors of any stage

          -  Underwent initial surgical management, including staging, of early stage disease or
             surgical debulking of advanced stage disease* NOTE: *Patients may delay surgical
             debulking, if clinically indicated, until after study entry; these patients may
             receive several courses of neoadjuvant chemotherapy prior to surgical debulking, but
             before study entry

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Hemoglobin ≥ 8.0 g/dL

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  Bilirubin normal

          -  Meets 1 of the following criteria:

               -  Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal
                  (ULN)

               -  AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

               -  AP ≤ 5 times ULN AND AST or ALT normal

        Renal

          -  Not specified

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for ≥ 3 months after
             completion of study treatment

          -  No peripheral neuropathy > grade 1

          -  No prior malignancy with a poor prognosis that is at risk of relapse during study
             participation, as determined by the principal investigator

          -  No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No concurrent chemotherapy for another malignancy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  Not specified

        Surgery

          -  See Disease Characteristics

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Howard G. Muntz, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00138242

Organization ID

VMRC-8837

Secondary IDs

CDR0000439927

Study Sponsor

Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center

Study Sponsor

Howard G. Muntz, MD, Principal Investigator, Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center

Verification Date

October 2006