Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00184093
First received: September 12, 2005
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

The purpose of this study is first to establish what is the ideal dose of gemcitabine, a chemotherapy agent, when given in combination with radiation. In addition, the investigators want to determine the side effects and the effectiveness of this combination. The investigators will also study several markers to try to identify markers or tests that will predict which patients will benefit more from this treatment.


Condition Intervention Phase
Uterine Cervical Cancer
Drug: Gemcitabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma: Analysis of Prognostic Factors and Determinants of Response: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Toxicity [ Time Frame: after 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response [ Time Frame: After 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: June 1999
Study Completion Date: May 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine weekly x 6 wks with concurrent external radiation
Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation
Drug: Gemcitabine
Gemcitabine weekly x 6 wks with concurrent external radiation

  Eligibility

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

Inclusion Criteria:

  • Patients with histologically confirmed bulky stage Ib or stage IIa cervical cancer. Bulky stage Ib disease is defined as tumor mass greater than 4 cms in diameter.
  • Cervical lesion which is measurable by physical examination.
  • No prior therapy for invasive cervical cancer.
  • GOG performance status 0-2
  • Signed informed consent
  • Patients must have adequate:

    • Bone marrow function: absolute granulocyte count > or = to 1500, platelet count > 100,000.
    • Renal function: creatinine < or = to 1.8 mg/dl
    • Hepatic function: bilirubin < or = to 1.5 x normal, SGOT and alkaline phosphatase < or = to 3 x normal

Exclusion Criteria:

  • Patients with a history of prior malignancy, except adequately treated basal cell or squamous cell carcinoma of the skin, or other cancer for which the patient has been disease free for at least five years.
  • Pregnant or lactating women. Women of reproductive age may not participate unless they have agreed to use an effective method of birth control.
  • Patients with uncontrolled infection.
  • Patients who are HIV positive
  • Patients with psychiatric or social conditions that would interfere with consent or follow-up.
  • Patients with any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  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: NCT00184093

Locations
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Lynda Roman, MD University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00184093     History of Changes
Other Study ID Numbers: 5C-99-1
Study First Received: September 12, 2005
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Cervical Carcinoma

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Carcinoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 16, 2014