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

NCT00184093 | Completed Phase 1 Results

• 1 other identifier: 5C-99-1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cervical Cancer

Keywords

Cervical Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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)

  Every 3 weeks from start of study until 30 days after the last dose of treatment

Secondary Outcomes (1)

• Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)

  Baseline to response (up to 24 months)

Study Arms (1)

Gemcitabine weekly x 6 wks with concurrent external radiation

EXPERIMENTAL

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

Drug: Gemcitabine

Interventions

Gemcitabine DRUG

Gemcitabine weekly x 6 wks with concurrent external radiation

Gemcitabine weekly x 6 wks with concurrent external radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Victoria Soto - Project Specialist
• Organization: USC Norris Comprehensive Cancer Center

Victoria.Soto@med.usc.edu

(323) 865-0454

Study Officials

• Lynda Roman, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: June 1, 1999
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2009
• Last Updated: August 15, 2017
• Results First Posted: August 15, 2017

Record last verified: 2017-07

Locations

US (1)