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

Primary Purpose

Uterine Cervical Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cervical Cancer focused on measuring Cervical Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • USC/Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine weekly x 6 wks with concurrent external radiation

Arm Description

Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation

Outcomes

Primary Outcome Measures

Toxicity (Number of Participants With Serious Adverse Events)
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)
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.

Full Information

First Posted
September 12, 2005
Last Updated
July 14, 2017
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT00184093
Brief Title
Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 1999 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Cancer
Keywords
Cervical Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine weekly x 6 wks with concurrent external radiation
Arm Type
Experimental
Arm Description
Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine weekly x 6 wks with concurrent external radiation
Primary Outcome Measure Information:
Title
Toxicity (Number of Participants With Serious Adverse Events)
Description
Summary of grade 3 or higher toxicities as per Common Toxicity Criteria version 2.0. Phase 1 and 2 Combined (N=35)
Time Frame
Every 3 weeks from start of study until 30 days after the last dose of treatment
Secondary Outcome Measure Information:
Title
Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)
Description
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.
Time Frame
Baseline to response (up to 24 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynda Roman, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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