NCT00004866

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 DX-8951f in treating women who have advanced or recurrent cancer of the cervix.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2000

Typical duration for phase_2

Geographic Reach
1 country

6 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

January 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

May 16, 2012

Status Verified

May 1, 2012

Enrollment Period

3.7 years

First QC Date

March 7, 2000

Last Update Submit

May 15, 2012

Conditions

Cervical Cancer

Keywords

stage III cervical cancerstage IV cervical cancerrecurrent cervical cancercervical squamous cell carcinoma

Interventions

exatecan mesylateDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed advanced or recurrent squamous cell carcinoma of the cervix not curable by surgery or radiotherapy * Measurable disease * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT or SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No active congestive heart failure * No uncontrolled angina * No myocardial infarction within the past 6 months Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No concurrent serious infection * No other malignancy within the past 5 years except nonmelanomatous skin cancer * No other life threatening illness * No psychosis, mental disability, or incompetence PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent biologic therapy Chemotherapy: * At least 4 weeks since prior chemotherapy * No more than 1 prior chemotherapy regimen (except chemotherapy for radiosensitization) * No prior camptothecin * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * At least 4 weeks since prior surgery * No concurrent surgery Other: * At least 4 weeks since other prior investigational drugs (including analgesics or antiemetics) * No other concurrent investigational drugs during or within 28 days after final dose of study drug * No concurrent drugs that induce or inhibit CYP3A enzyme

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

Sponsors & Collaborators

Study Sites (6)

St. Luke's-Roosevelt Hospital

New York, New York, 10019, United States

Location

Albert Einstein Clinical Cancer Center

The Bronx, New York, 10461, United States

Location

Ruppert Health Center

Toledo, Ohio, 43614, United States

Location

Brookview Research, Inc.

Nashville, Tennessee, 37203, United States

Location

Texas Oncology PA (TOPA) at Baylor-Sammons

Dallas, Texas, 75246, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

exatecan

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Robert L. DeJager, MD, FACP

    Daiichi Sankyo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2000

First Posted

January 27, 2003

Study Start

January 1, 2000

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

May 16, 2012

Record last verified: 2012-05

Locations

US(6)