NCT00003382

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 I trial to study the effectiveness of combination chemotherapy consisting of gemcitabine and topotecan in treating patients with refractory or recurrent ovarian or fallopian tube cancer.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

6 active sites

Status
terminated

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, 1998

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.7 years until next milestone

First Posted

Study publicly available on registry

July 15, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Last Updated

June 10, 2013

Status Verified

May 1, 2006

Enrollment Period

7.9 years

First QC Date

November 1, 1999

Last Update Submit

June 7, 2013

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer

Keywords

stage I ovarian epithelial cancerstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerfallopian tube cancerprimary peritoneal cavity cancer

Interventions

filgrastimBIOLOGICAL
gemcitabine hydrochlorideDRUG
topotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically documented refractory or recurrent ovarian epithelial or fallopian tube cancer * No borderline ovarian cancer * Extra-ovarian papillary serous tumors eligible * Must not be eligible for any higher priority phase II or III GOG protocol PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * GOG 0-2 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * SGOT no greater than 3 times upper limit of normal (ULN) * Bilirubin no greater than 1.5 mg/dL * Elevated levels of alkaline phosphatase allowed Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No angina pectoris or clinically significant multifocal uncontrolled cardiac dysrhythmias * No uncontrolled hypertension Other: * No other active malignancy * No prior malignancy within the past 5 years except nonmelanomatous skin cancer * No active infection * No underlying medical problem that would prevent compliance * No known hypersensitivity to E. coli-derived drug preparations * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Must have received at least 1 prior platinum- and paclitaxel-based regimen * At least 4 weeks since prior chemotherapy * No prior topotecan and/or gemcitabine * No prior chemotherapy for a different prior malignancy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to more than 10% of bone marrow * At least 2 weeks since limited field radiation therapy 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 (6)

Community Hospital of Los Gatos

Los Gatos, California, 95032, United States

Location

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Women's Cancer Center

Palo Alto, California, 94304, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Holden Comprehensive Cancer Center at The University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Related Publications (1)

  • Chen MD, Fleming GF, Mitchell S, Horowitz I. A phase I trial of gemcitabine and topotecan in previously treated ovarian or peritoneal cancer: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Jan;100(1):111-5. doi: 10.1016/j.ygyno.2005.07.114. Epub 2005 Sep 8.

    PMID: 16150481RESULT

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

FilgrastimGemcitabineTopotecan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCamptothecinAlkaloids

Study Officials

  • Ming-teh D. Chen, MD

    Women's Cancer Center - Los Gatos

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 15, 2003

Study Start

May 1, 1998

Primary Completion

April 1, 2006

Last Updated

June 10, 2013

Record last verified: 2006-05

Locations

US(6)