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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
docetaxel
adjuvant therapy
Sponsored by
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center

Outcomes

Primary Outcome Measures

Reduction rate of myelosuppression

Secondary Outcome Measures

Quality of life as assessed by the Functional Assessment of Cancer Therapy -Ovarian (FACT-O) questionnaire
Toxicity
Clinical response rate
Findings at second look surgery
Time to disease progression

Full Information

First Posted
August 29, 2005
Last Updated
June 25, 2013
Sponsor
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00138242
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Reduction rate of myelosuppression
Secondary Outcome Measure Information:
Title
Quality of life as assessed by the Functional Assessment of Cancer Therapy -Ovarian (FACT-O) questionnaire
Title
Toxicity
Title
Clinical response rate
Title
Findings at second look surgery
Title
Time to disease progression

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard G. Muntz, MD
Organizational Affiliation
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98111-0900
Country
United States

12. IPD Sharing Statement

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

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