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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00217568
First received: September 20, 2005
Last updated: September 20, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Cavity Cancer
Biological: pegfilgrastim
Drug: carboplatin
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Response rates (complete and partial response) [ Designated as safety issue: No ]
  • Relapse rates [ Designated as safety issue: No ]
  • Event-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Study Start Date: May 2005
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217568

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Pacific Gynecology Specialists
Seattle, Washington, United States, 98104
University of Washington School of Medicine
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Leona A. Holmberg, MD, PhD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00217568     History of Changes
Other Study ID Numbers: PSOC 1702, PSOC-1702, AVENTIS-PSOC-1702, PSOC-IRB-4861, CDR0000441307
Study First Received: September 20, 2005
Last Updated: September 20, 2010
Health Authority: United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:
recurrent ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Carboplatin
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014