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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00320983
• Other study ID #: 1601C
• Status: Completed
• Phase: Phase 1
• First received: May 1, 2006
• Last updated: January 6, 2010
• Start date: March 2002
• Est. completion date: December 2005

Study information

• Verified date: October 2008
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2005
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Topotecan
Topotecan
• Cisplatin
Cisplatin

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease progression		disease progress or complete remission	No