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


Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Reduction rate of myelosuppression

Safety Issue:

No

Principal Investigator

Howard G. Muntz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center

Authority:

United States: Federal Government

Study ID:

VMRC-8837

NCT ID:

NCT00138242

Start Date:

December 2004

Completion Date:

October 2006

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Floyd & Delores Jones Cancer Institute at Virginia Mason Medical CenterSeattle, Washington  98111