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

This study has been completed.
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00320983
First received: May 1, 2006
Last updated: January 6, 2010
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Cervical Cancer
Drug: Topotecan
Drug: Cisplatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Adjuvant Topotecan and Cisplatin With Concurrent Radiation Therapy for Advanced Cervical Cancer

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • disease progression [ Time Frame: disease progress or complete remission ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: March 2002
Study Completion Date: December 2005
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Topotecan
    Topotecan
    Other Name: Hycamtin
    Drug: Cisplatin
    Cisplatin
    Other Name: Platinol AQ
Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320983

Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Harriet Smith, MD University of New Mexico
  More Information

No publications provided

Responsible Party: Harriet O Smith, MD; Principal Investigator, University of New Mexico CRTC
ClinicalTrials.gov Identifier: NCT00320983     History of Changes
Other Study ID Numbers: 1601C
Study First Received: May 1, 2006
Last Updated: January 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
Cancer
Cervix

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Topotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014