search
Back to results

Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity Cancer

Primary Purpose

Ovarian Cancer, Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pegfilgrastim
carboplatin
docetaxel
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, peritoneal cavity cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer Stage III or IV disease No borderline tumors Measurable or evaluable disease Measurable disease, defined as evidence of disease by physical examination or radiographic evaluation Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests performed ≥ 1 week apart) In first relapse Platinum-sensitive disease, defined as initial relapse > 6 months after completion of a platinum-based regimen PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy Not specified Hematopoietic Platelet count ≥ 100,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Hepatic Bilirubin normal Meets 1 of the following criteria: SGOT and/or SGPT ≤ 1.5 times upper limit of normal (ULN) AND alkaline phosphatase (AP) ≤ 2.5 times ULN SGOT and/or SGPT ≤ 5.0 times ULN AND AP normal Renal Creatinine ≤ 2.0 mg/dL Creatinine clearance > 50 mL/min Cardiovascular LVEF ≥ 50% No poorly controlled arrhythmia No unstable coronary artery disease or myocardial infarction within the past year Other HIV negative No pre-existing peripheral neuropathy > grade 2 No history of allergy to study drugs PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy Not specified Radiotherapy At least 3 weeks since prior radiotherapy and recovered Surgery Recovered from recent prior surgery Other No concurrent myelosuppressive therapy

Sites / Locations

  • Pacific Gynecology Specialists
  • Fred Hutchinson Cancer Research Center
  • University of Washington School of Medicine

Outcomes

Primary Outcome Measures

Toxicity
Response rates (complete and partial response)
Relapse rates
Event-free survival
Overall survival

Secondary Outcome Measures

Full Information

First Posted
September 20, 2005
Last Updated
September 20, 2010
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00217568
Brief Title
Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity Cancer
Official Title
A Phase II Trial of Docetaxel and Carboplatin for First Relapsed Platinum-Sensitive Stage III and IV Advanced Ovarian Cancer or Peritoneal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

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 relapsed stage III or stage IV ovarian epithelial or primary peritoneal cavity cancer.
Detailed Description
OBJECTIVES: Determine the toxicity of docetaxel and carboplatin in patients with platinum-sensitive stage III or IV ovarian epithelial or primary peritoneal cavity cancer in first relapse. Determine the response rates (complete and partial response) in patients treated with this regimen. Determine relapse rates and event-free survival and overall survival rates in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2 . Treatment repeats every 21 days for up to 6 courses. After completion of study treatment, patients are followed at 3 weeks, every 3 months for 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Peritoneal Cavity Cancer
Keywords
recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, peritoneal cavity cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
pegfilgrastim
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
docetaxel
Primary Outcome Measure Information:
Title
Toxicity
Title
Response rates (complete and partial response)
Title
Relapse rates
Title
Event-free survival
Title
Overall survival

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer Stage III or IV disease No borderline tumors Measurable or evaluable disease Measurable disease, defined as evidence of disease by physical examination or radiographic evaluation Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests performed ≥ 1 week apart) In first relapse Platinum-sensitive disease, defined as initial relapse > 6 months after completion of a platinum-based regimen PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy Not specified Hematopoietic Platelet count ≥ 100,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Hepatic Bilirubin normal Meets 1 of the following criteria: SGOT and/or SGPT ≤ 1.5 times upper limit of normal (ULN) AND alkaline phosphatase (AP) ≤ 2.5 times ULN SGOT and/or SGPT ≤ 5.0 times ULN AND AP normal Renal Creatinine ≤ 2.0 mg/dL Creatinine clearance > 50 mL/min Cardiovascular LVEF ≥ 50% No poorly controlled arrhythmia No unstable coronary artery disease or myocardial infarction within the past year Other HIV negative No pre-existing peripheral neuropathy > grade 2 No history of allergy to study drugs PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy Not specified Radiotherapy At least 3 weeks since prior radiotherapy and recovered Surgery Recovered from recent prior surgery Other No concurrent myelosuppressive therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leona A. Holmberg, MD, PhD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pacific Gynecology Specialists
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity Cancer

We'll reach out to this number within 24 hrs