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A Phase II Trial of Docetaxel and Carboplatin for First Relapsed Platinum-Sensitive Stage III and IV Advanced Ovarian Cancer or Peritoneal Carcinoma


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

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Trial Information

A Phase II Trial of Docetaxel and Carboplatin for First Relapsed Platinum-Sensitive Stage III and IV Advanced Ovarian Cancer or Peritoneal Carcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity

Safety Issue:

Yes

Principal Investigator

Leona A. Holmberg, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

PSOC 1702

NCT ID:

NCT00217568

Start Date:

May 2005

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location

Fred Hutchinson Cancer Research Center Seattle, Washington  98109
University of Washington School of Medicine Seattle, Washington  98195
Pacific Gynecology Specialists Seattle, Washington  98104