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Completed

NCT Number: NCT00184093

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gemcitabine

Drug

Gemcitabine weekly x 6 wks with concurrent external radiation

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study 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

Important dates

Study start
1999
Primary completion
2008
Study completion
2009
First posted
Sep 16, 2005
Registry last updated
Aug 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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