NCT00217568

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Last Updated

September 21, 2010

Status Verified

September 1, 2010

Enrollment Period

10 months

First QC Date

September 20, 2005

Last Update Submit

September 20, 2010

Conditions

Ovarian CancerPeritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerperitoneal cavity cancer

Outcome Measures

Primary Outcomes (5)

  • Toxicity

  • Response rates (complete and partial response)

  • Relapse rates

  • Event-free survival

  • Overall survival

Interventions

pegfilgrastimBIOLOGICAL
carboplatinDRUG
docetaxelDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Pacific Gynecology Specialists

Seattle, Washington, 98104, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

pegfilgrastimCarboplatinDocetaxel

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Leona A. Holmberg, MD, PhD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

May 1, 2005

Primary Completion

March 1, 2006

Last Updated

September 21, 2010

Record last verified: 2010-09

Locations

US(3)