Weekly IV Topotecan and Cisplatin With Radiation in Cervical Carcinoma - Full Text View

Sponsored by:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00257816

Purpose

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.

Condition	Intervention	Phase
Cervical Cancer	Drug: Topotecan Drug: Cisplatin	Phase II

MedlinePlus related topics: Cancer Radiation Therapy

Drug Information available for: Cisplatin Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Feasibility Study of Weekly IV Topotecan and Cisplatin With Concurrent Pelvic Radiation in the Treatment of Stages IB2 - IVA Cervical Carcinoma

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

To assess the feasibility and toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the efficacy [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	April 2004
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

2 mg/m2 IV on days 1, 8, 15, 22, 29 and once during parametrial boost (6 cycles)

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with primary, previously untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, Stage I-2, II-B, III-B, IV-A.
Patients with negative, non-suspicious para-aortic nodes determined by lymphangiogram, CT, MRI or lymphadenectomy.
Patients with adequate bone marrow function: ANC greater than or equal to 1,500/mcl, platelets greater than or equal to 100,000/mcl, and Hemoglobin > 10 mg/dl.
Patients with adequate renal function: Creatinine equal to or less than 1.5 mg%.
Patients with adequate hepatic function: Bilirubin less than or equal to 1.5 x normal and SGOT and Alkaline phosphatase less than or equal to 3 x normal.
Patients who have signed an approved informed consent.
Patients with GOG Performance Status of 0, 1, 2, or 3.
Patients of childbearing potential must have a negative serum pregnancy test and use an effective form of contraception.
Patients who are suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation.

Exclusion Criteria:

Patients who cannot be or have not been adequately clinically staged.
Patients with lower one-third vaginal involvement.
Patients with septicemia or severe infection.
Patients with circumstances that will not permit completion of the study or required follow-up.
Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
Patients with carcinoma of the cervical stump.
Patients who are lactating or pregnant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257816

Contacts

Contact: Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center

1-877-UC-STUDY

UCstudy@uci.edu

Locations

United States, California
Chao Family Comprehensive Cancer Center	Recruiting
Orange, California, United States, 92868
Principal Investigator: Bradley Monk, MD

Sponsors and Collaborators

University of California, Irvine

Investigators

Principal Investigator:

Bradley Monk, MD

Chao Family Comprehensive Cancer Center

More Information

No publications provided

Responsible Party:	University of California, Irvine Medical Center ( Bradley J. Monk, MD )
Study ID Numbers:	UCI 03-33
Study First Received:	November 21, 2005
Last Updated:	March 26, 2008
ClinicalTrials.gov Identifier:	NCT00257816 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Cervical Cancer

Study placed in the following topic categories:

Radiation-Sensitizing Agents
Cisplatin
Topotecan
Carcinoma

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Cisplatin
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Enzyme Inhibitors
Topotecan
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009