NCT00003065

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 topotecan and paclitaxel in treating patients who have recurrent or metastatic cancer of the cervix.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 1997

Longer than P75 for phase_2

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

January 1, 1997

Completed
2.8 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
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

January 6, 2014

Status Verified

September 1, 2003

First QC Date

November 1, 1999

Last Update Submit

January 3, 2014

Conditions

Cervical Cancer

Keywords

recurrent cervical cancerstage IVB cervical cancerstage IVA cervical cancercervical squamous cell carcinomacervical adenocarcinoma

Interventions

filgrastimBIOLOGICAL
paclitaxelDRUG
topotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: * Histologically confirmed recurrent, persistent or metastatic cervical carcinoma (squamous or adenocarcinoma), with no potentially curative standard treatment * Measurable disease or evaluable disease PATIENT CHARACTERISTICS: Age: * 18 to physiological 60 Performance status: * ECOG 0-2 Life expectancy: * Greater than 2 months Hematopoietic: * WBC greater than 3000/mm3 * Platelet count greater than 100,000/mm3 Hepatic: * Bilirubin less than 1.5 times normal * SGOT/SGPT less than 1.5 times normal Renal: * BUN less than 1.5 times normal * Creatinine less than 1.5 times normal * Creatinine clearance greater than 50 mL/min Other: * Ineligible for other high priority national or institutional study * Not pregnant or nursing * HIV negative * No prior malignancy except nonmelanoma skin cancer * No serious medical or psychiatric illness preventing treatment or informed consent PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Greater than 4 weeks since prior chemotherapy * No greater than 2 prior chemotherapy regimens * No prior taxane or camptothecin Endocrine therapy: * No concurrent hormonal therapy except that required for nondisease related conditions (e.g., insulin for diabetes) Radiotherapy: * Greater than 4 weeks since prior radiation therapy * No concurrent radiation therapy Surgery: * Greater than 4 weeks since prior surgery

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

Related Publications (1)

  • Tiersten AD, Selleck MJ, Hershman DL, Smith D, Resnik EE, Troxel AB, Brafman LB, Shriberg L. Phase II study of topotecan and paclitaxel for recurrent, persistent, or metastatic cervical carcinoma. Gynecol Oncol. 2004 Feb;92(2):635-8. doi: 10.1016/j.ygyno.2003.11.019.

    PMID: 14766258RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

FilgrastimPaclitaxelTopotecan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Amy D. Tiersten, MD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

January 1, 1997

Study Completion

February 1, 2004

Last Updated

January 6, 2014

Record last verified: 2003-09

Locations

US(1)