NCT00003560

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in treating patients who have stage III or stage IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1998

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

January 6, 2014

Status Verified

September 1, 2003

First QC Date

November 1, 1999

Last Update Submit

January 3, 2014

Conditions

Endometrial CancerFallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer

Keywords

stage III ovarian epithelial cancerstage IV ovarian epithelial cancerstage III endometrial carcinomastage IV endometrial carcinomaendometrial papillary serous carcinomafallopian tube cancerprimary peritoneal cavity cancer

Interventions

carboplatinDRUG
docetaxelDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed previously untreated ovarian cancer, fallopian tube carcinoma, papillary serous cancer of the uterus, or primary peritoneal carcinoma * Suboptimally debulked stage III or suboptimally or optimally debulked stage IV * Measurable or evaluable disease * CNS lesions, lytic bone lesions, and radiated lesions (unless there is documented progression after radiotherapy) are not considered measurable * CA 125 levels above 49 units/mL in the absence of cirrhosis or nonmalignant gross ascites are considered evaluable * Ineligible for other high-priority national or institutional study PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-1 Life expectancy: * More than 2 months Hematopoietic: * WBC greater than 3,000/mm3 * Platelet count greater than 100,000/mm3 Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGOT and/or SGPT less than 2.5 times ULN OR * SGOT and/or SGPT no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN OR * Alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT no greater than ULN * No SGOT and/or SGPT greater than 1.5 times ULN with alkaline phosphatase greater than 2.5 times ULN * Alkaline phosphatase less than 350 U/L Renal: * BUN less than 1.5 times normal * Creatinine less than 1.5 times ULN Other: * No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or skin cancer * No other serious medical or psychiatric illness * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormone therapy Radiotherapy: * See Disease Characteristics * No prior radiotherapy Surgery: * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Endometrial NeoplasmsFallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

CarboplatinDocetaxel

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesFallopian Tube DiseasesAdnexal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Amy D. Tiersten, MD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

May 1, 1998

Last Updated

January 6, 2014

Record last verified: 2003-09

Locations

US(1)