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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00217568
• Other study ID #: PSOC 1702
• Secondary ID: PSOC-1702AVENTIS
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2005
• Last updated: September 20, 2010
• Start date: May 2005

Study information

• Verified date: September 2010
• Source: Fred Hutchinson Cancer Research Center
• 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 relapsed stage III or stage IV ovarian epithelial or primary peritoneal cavity cancer.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cavity Cancer
• Peritoneal Neoplasms

Intervention

Biological:
• pegfilgrastim

Drug:
• carboplatin

• docetaxel

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Pacific Gynecology Specialists	Seattle	Washington
United States	University of Washington School of Medicine	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity			Yes
Primary	Response rates (complete and partial response)			No
Primary	Relapse rates			No
Primary	Event-free survival			No
Primary	Overall survival			No