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

January 6, 2010 updated by: University of New Mexico

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

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

Study Overview

Status

Completed

Conditions

Cervical Cancer

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New Mexico
  - Albuquerque, New Mexico, United States, 87131
    - University of New Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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
Patients may have measurable disease (defined as lesions which can be measured in at least two (2) dimensions by physical examination or any medical imaging technique). Inability to measure disease will not constitute 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

Exclusion Criteria:

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
disease progression Time Frame: disease progress or complete remission	disease progress or complete remission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Investigators

Principal Investigator: Harriet Smith, MD, University of New Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

May 1, 2006

First Submitted That Met QC Criteria