NCT00002813

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 combination chemotherapy with cisplatin and vinorelbine in treating patients with refractory or recurrent squamous cell cervical cancer that has not responded to local therapy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

9 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

August 1, 1997

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

May 21, 2004

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Last Updated

May 27, 2013

Status Verified

March 1, 2008

Enrollment Period

7.2 years

First QC Date

November 1, 1999

Last Update Submit

May 24, 2013

Conditions

Cervical Cancer

Keywords

recurrent cervical cancerstage IVB cervical cancercervical squamous cell carcinoma

Interventions

cisplatinDRUG
vinorelbine tartrateDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven advanced, persistent, or recurrent squamous cell carcinoma of the cervix that failed local therapy and is considered incurable Bidimensionally measurable abdominal, pelvic, or other lesion by palpation, x- ray, or ultrasound If sole site of measurable disease previously irradiated, then documented disease progression at that site required PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Karnofsky 60%-100% Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least 50 mL/min if creatinine greater than 1.2 mg/dL Other: No clinically significant infection No preexisting, clinically significant peripheral neuropathy unless due to cancer No other prior or concurrent malignancy except nonmelanomatous skin cancer No psychological, familial, sociological, or geographical condition that would preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy except for radiosensitization Endocrine therapy: Not specified Radiotherapy: See Chemotherapy Recovered from the toxic effects of any recent radiotherapy Surgery: Recovered from the toxic effects of any recent surgery

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

Sponsors & Collaborators

Study Sites (9)

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21231, United States

Location

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

Cancer Center of Albany Medical Center

Albany, New York, 12208, United States

Location

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157-1082, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Brookview Research, Inc.

Nashville, Tennessee, 37203, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Morris M, Blessing JA, Monk BJ, McGehee R, Moore DH. Phase II study of cisplatin and vinorelbine in squamous cell carcinoma of the cervix: a gynecologic oncology group study. J Clin Oncol. 2004 Aug 15;22(16):3340-4. doi: 10.1200/JCO.2004.12.006.

    PMID: 15310778RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

CisplatinVinorelbine

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)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Mitchell Morris, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 21, 2004

Study Start

August 1, 1997

Primary Completion

October 1, 2004

Last Updated

May 27, 2013

Record last verified: 2008-03

Locations

US(9)