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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00138242
• Other study ID #: VMRC-8837
• Secondary ID: CDR0000439927AVE
• Status: Completed
• Phase: Phase 2
• First received: August 29, 2005
• Last updated: June 25, 2013
• Start date: December 2004
• Est. completion date: October 2006

Study information

• Verified date: October 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• carboplatin

• docetaxel

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
United States	Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction rate of myelosuppression			No
Secondary	Quality of life as assessed by the Functional Assessment of Cancer Therapy -Ovarian (FACT-O) questionnaire			No
Secondary	Toxicity			Yes
Secondary	Clinical response rate			No
Secondary	Findings at second look surgery			No
Secondary	Time to disease progression			No