Clinical trial NCT00217568: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Peritoneal Cavity Cancer
Keywords: recurrent ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
peritoneal cavity cancer
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Toxicity
measure: Response rates (complete and partial response)
measure: Relapse rates
measure: Event-free survival
measure: Overall survival
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Pacific Gynecology Specialists
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Leona A. Holmberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: