NCT00004081

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating women who have ovarian epithelial cancer or primary peritoneal cancer that has not responded to previous treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 ovarian-cancer

Timeline
Completed

Started Jul 1999

Geographic Reach
1 country

1 active site

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

July 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

August 13, 2012

Status Verified

August 1, 2012

Enrollment Period

2.5 years

First QC Date

December 10, 1999

Last Update Submit

August 9, 2012

Conditions

Ovarian CancerPeritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancerperitoneal cavity cancer

Interventions

docetaxelDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial or primary peritoneal serous cancer that is resistant to platinum therapy * Platinum resistance as defined by one of the following: * Relapse within 6 months of platinum based chemotherapy * Residual disease after completion of platinum based chemotherapy * Disease progression while receiving platinum based chemotherapy * Marker only relapse (CA-125 elevation) and measurable disease * Bidimensionally measurable disease on exam or CT scan PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Performance status: * ECOG 0-2 Life expectancy: * Greater than 2 months Hematopoietic: * WBC at least 3,000/mm3 * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * SGPT or SGOT no greater than 1.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * Acceptable cardiac exam * No active cardiac ischemia Pulmonary: * Acceptable pulmonary exam * No active pulmonary infection or compromise Other: * Not pregnant or nursing * No severe peripheral neuropathy (grade 2 or greater) * No other significant psychiatric or medical conditions that would interfere with compliance * No other malignancies within the past 3 years, except: * Limited basal or squamous cell skin cancer * Carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior cytokine therapy Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy for ovarian epithelial or peritoneal serous cancer * Prior paclitaxel allowed * No prior docetaxel * At least 3 years since prior chemotherapy for other disease Endocrine therapy: * Not specified Radiotherapy: * No prior pelvic radiotherapy Surgery: * Not specified

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

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Berkenblit A, Seiden MV, Matulonis UA, Penson RT, Krasner CN, Roche M, Mezzetti L, Atkinson T, Cannistra SA. A phase II trial of weekly docetaxel in patients with platinum-resistant epithelial ovarian, primary peritoneal serous cancer, or fallopian tube cancer. Gynecol Oncol. 2004 Dec;95(3):624-31. doi: 10.1016/j.ygyno.2004.08.028.

    PMID: 15581974RESULT

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Docetaxel

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)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Stephen A. Cannistra, MD

    Beth Israel Deaconess Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

December 10, 1999

First Posted

January 27, 2003

Study Start

July 1, 1999

Primary Completion

January 1, 2002

Study Completion

March 1, 2003

Last Updated

August 13, 2012

Record last verified: 2012-08

Locations

US(1)