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Weekly IV Topotecan and Cisplatin With Radiation in Cervical Carcinoma

NCT00257816 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-02-05

No results posted yet for this study

Summary

There will be approximately 14,000 new patients with invasive cervical cancer diagnosed in the United States in 2003 with about 4,000 deaths from this disease. This accounts for approximately 17% of all deaths due to gynecologic cancers. Radiation has been the primary treatment modality for locoregionally advanced cervical cancer. Recent trials of concomitant systemic cisplatin chemotherapy and radiation have shown high response rates (RR) with improvements in durable remissions and overall survival. Though the incidence and mortality in the U.S. dropped steadily from years 1940 to 2000, there has recently been a plateau, arresting the decline. With the routine addition of systemic Cisplatin (CDDP) chemotherapy to local regional radiation, mortality from advanced cervical cancer in the United States is expected to further decrease. However, further advances in this disease are needed.

Conditions

Interventions

DRUG

Topotecan

(First stage of accrual, 6 patients)-2 mg/m2 IV on days 1, 8, 15, 22, 29 and once during parametrial boost (6 cycles) If none or 1 of the 6 patients in the first Stage of accrual finish the prescribed therapy in over 8 weeks, then the second Stage of accrual (an additional 6 patients) will increase the Topotecan dose to 3 mg/m2 on days 1, 8, 15, 22, 29 and once during parametrical boost (6 cycles). If 2 or 3 of the patients in the first stage of accrual finish the prescribed therapy in over 8 weeks, the dose of the Topotecan will remain the same in the second Phase of accrual. If 4 or more of the patients in the first stage of accrual finish the prescribed therapy in over 8 weeks, there will be no second phase of accrual.

DRUG

Cisplatin

40 mg/m2 IV (Maximum total dose of 70 mg) on days 1, 8, 15, 22, 29 and once during parametrial boost (6 cycles)

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Bradley Monk, MD · Chao Family Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2007-12-17
Completion
2007-12-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00257816 on ClinicalTrials.gov