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

Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center

Status and phase

Completed

Phase 2

Conditions

Primary Peritoneal Cavity Cancer

Fallopian Tube Cancer

Ovarian Cancer

Treatments

Procedure: adjuvant therapy

Drug: docetaxel

Drug: carboplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00138242

CDR0000439927 (Registry Identifier)

VMRC-8837

AVENTIS-VMRC-8837

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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