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CompletedNCT00217568Updated Sep 21, 2010

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

A Phase 2 interventional study of pegfilgrastim and carboplatin in Ovarian Cancer and Peritoneal Cavity Cancer, sponsored by Fred Hutchinson Cancer Center. Completed at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-21.

Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Ovarian Cancer
  • Peritoneal Cavity Cancer

Keywords

  • recurrent ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • peritoneal cavity cancer
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

Browse Ovarian Neoplasms studies →

Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)

Interventions

  • Biologicalpegfilgrastim
  • Drugcarboplatin
  • Drugdocetaxel
06

What researchers measure

Primary outcomes

  1. Toxicity

  2. Response rates (complete and partial response)

  3. Relapse rates

  4. Event-free survival

  5. Overall survival

07

Study locations

3 sites
  • Pacific Gynecology Specialists
    Seattle, Washington 98104, United States
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109-1024, United States
  • University of Washington School of Medicine
    Seattle, Washington 98195, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00217568
Lead sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
First posted
Sep 22, 2005
Start date
May 2005
Primary completion
Mar 2006
Last update
Sep 21, 2010

Study contacts

Leona A. Holmberg, MD, PhD
principal investigator · Fred Hutchinson Cancer Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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