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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: July 14, 2017
Last verified: July 2017
  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: Intervention Model: Single Group Assignment
Masking: None (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 (Number of Participants With Serious Adverse Events) [ Time Frame: Every 3 weeks from start of study until 30 days after the last dose of treatment ]
    Summary of grade 3 or higher toxicities as per Common Toxicity Criteria version 2.0. Phase 1 and 2 Combined (N=35)


Secondary Outcome Measures:
  • Best Overall Response of Either a Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline to response (up to 24 months) ]

    Participants who complete the 6 weeks of chemotherapy and radiation or who experience dose limiting toxicity or who progress at any time prior to completion of the 6 weeks of chemotherapy and radiation will be evaluable for response.

    Complete response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No disease related symptoms. No evidence of nonevaluable disease, including normalization of markers and other abnormal lab values. All measurable, evaluable, and nonevaluable lesions and sites must be assessed using the same technique as baseline.

    Partial response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using the same techniques as baseline.



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   (Adult, Senior)
Sexes 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

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
Results First Received: July 14, 2017
Last Updated: July 14, 2017

Keywords provided by University of Southern California:
Cervical Carcinoma

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

ClinicalTrials.gov processed this record on August 21, 2017