Study of Adjuvant Topotecan and Cisplatin With Concurrent Radiation Therapy for Advanced Cervical Cancer

NCT ID: NCT00320983

Last Updated: 2010-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2005-12-31

Brief Summary

A Phase I Study of Adjuvant Topotecan and Cisplatin with Concurrent Radiation Therapy for Advanced Cervical Cancer.

Detailed Description

Examines the effects of Topotecan and Cisplatin with radiation for advanced cervical cancer

Conditions

Cervical Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Topotecan

Topotecan

Intervention Type: DRUG

Cisplatin

Cisplatin

Intervention Type: DRUG

Other Intervention Names

Hycamtin; Platinol AQ

Eligibility Criteria

Inclusion Criteria

• Patients with histologically confirmed advanced cervical carcinoma who, following optional surgical staging, are not deemed to be curable by either surgery or radiotherapy alone. This includes patients with stages IIB, IIIA, IIIB or IVA and stages IB or IIA who in addition have one of the following risk factors:

• Primary tumor > 6 cm
• Positive pelvic and/or para-aortic lymph nodes (resected or unresected)
• Positive surgical margins
• Depth of invasion greater than 50 % and positive capillary-lymphatic space involvement
• Eligible cell types include squamous, adenosquamous and adenocarcinoma of the cervix

Exclusion Criteria

• Patients with GOG performance status of 0, 1, or 2.
• Patients will have recovered from the effects of recent surgery and should be free of clinically significant infection.
• Patients must have adequate:

• Bone marrow function: WBC greater than or equal to 3,000 cells/mm3, platelet count greater than or equal to 100,000 cells/mm3, and granulocyte count greater than or equal to 1,500 cells/mm3.
• Renal function: Creatinine less than or equal to 2.0 mg/dl.
• Hepatic function: Bilirubin less than or equal to 1.5 x institutional normal, SGOT and alkaline phosphatase less than or equal to 3 x institutional normal.
• Patients must have signed an approved informed consent.
• Patients have met the pre-entry requirements specified in Section 7.0

• Patients with GOG performance of 3 or 4.
• Patients with another malignancy, prior or concomitant, other than skin (excluding melanoma).
• Patients with septicemia, severe infection, gastrointestinal bleeding, or intestinal obstruction.
• Patients with anatomic abnormalities requiring modification of radiation fields (pelvic kidney, renal transplant, etc.).
• Patient with recurrent cervical cancer
• Patients who have received prior pelvic radiation
• Pregnant women and women of childbearing potential not using an effective form of contraception.
• History of thrombus (10/28/02)
• History of unstable angina or MI within the past six months. Patients with evidence of abnormal cardiac conduction (e.g. bundle branch block, heart block) are eligible if their disease has been stable for the past six months. (10/28/02)

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

University of New Mexico CRTC

Principal Investigators

Harriet Smith, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

University of New Mexico

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

1601C

Identifier Type: -

Identifier Source: org_study_id