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Topotecan, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00287911
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : December 2, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Tracking Information
First Submitted Date  ICMJE February 6, 2006
First Posted Date  ICMJE February 7, 2006
Last Update Posted Date December 2, 2017
Study Start Date  ICMJE February 2005
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2010)
Maximum tolerated dose of topotecan [ Time Frame: Week 3 After First Course of Therapy ]
Adequate Response Trial Minimum length of trial to evaluate response is defined as receiving the first course of chemotherapy and living at least three weeks for repeat measurement to be performed.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topotecan, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Cervical Cancer
Official Title  ICMJE A Phase I Study of Adjuvant Topotecan and Cisplatin With Concurrent Radiation Therapy for Advanced Cervical Cancer
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Topotecan and cisplatin may make tumor cells more sensitive to radiation therapy. Giving topotecan and cisplatin together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with cisplatin and radiation therapy in treating patients with advanced cervical cancer.

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of topotecan when administered with cisplatin in patients with advanced cervical cancer.
  • Identify any unique toxicities associated with administering radiotherapy along with adjuvant cisplatin and topotecan in patients with cervical cancer.
  • Determine the feasibility of administering continuous infusion topotecan chemotherapy together with radiation therapy.
  • Assess the quality of life of patients treated with this regimen.

OUTLINE: This is a dose-escalation study of topotecan.

Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36. Some patients may also undergo brachytherapy. Patients also receive cisplatin intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36 and topotecan IV continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Quality of life is assessed at baseline and at 4 and 14 weeks after completion of study treatment.

After completion of study treatment, patients are followed periodically.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • Drug: cisplatin
    intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36
    Other Names:
    • cisplatinum
    • CDDP
    • Platinol AQ
  • Drug: topotecan hydrochloride
    intravenously continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36 -Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined
    Other Name: Hycamtin
  • Radiation: brachytherapy
    Some patients may also undergo brachytherapy
  • Radiation: radiation therapy
    once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36
    Other Name: radiation
Study Arms  ICMJE Experimental: Combo Chemotherapy and Radiation

Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36. Some patients may also undergo brachytherapy. Patients also receive cisplatin intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36 and topotecan IV continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Interventions:
  • Drug: cisplatin
  • Drug: topotecan hydrochloride
  • Radiation: brachytherapy
  • Radiation: radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2010)
18
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed cervical carcinoma

    • Deemed not curable by surgery or radiotherapy alone
    • The following stages are eligible:

      • Stage IIB
      • Stage IIIA or IIIB
      • Stage IVA
      • Stage IB or IIA with ≥ 1 of the following risk factors:

        • Primary tumor ≥ 6 cm
        • Positive pelvic and/or para-aortic lymph nodes (resected or unresected)
        • Positive surgical margins
        • Depth of invasion > 50% and positive capillary-lymphatic space involvement
  • The following histologic subtypes are eligible:

    • Squamous
    • Adenosquamous
    • Adenocarcinoma
  • No recurrent cervical cancer
  • Gynecologic Oncology Group (GOG) performance status 0, 1, or 2
  • White blood cells (WBC) ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Granulocyte count ≥ 1,500/mm^3
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin ≤ 1.5 times institutional normal
  • Serum glutamic oxaloacetic transaminase (SGOT) and alkaline phosphatase ≤ 3 times institutional normal
  • No other prior or concurrent malignancies other than skin (excluding melanoma)
  • No septicemia, severe infection, gastrointestinal bleeding, or intestinal obstruction
  • No anatomic abnormalities (e.g., pelvic kidney or renal transplant) requiring modification of radiation fields
  • Fertile patients must use effective contraception
  • Negative pregnancy test
  • Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block) are eligible if disease is stable for the past 6 months
  • Recovered from recent surgery

Exclusion Criteria:

  • Prior pelvic radiation
  • Pregnant or nursing
  • History of thrombus
  • History of unstable angina or myocardial infarction within the past 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00287911
Other Study ID Numbers  ICMJE CDR0000452043
UMN-2001LS041 ( Other Identifier: CPRC, University of Minnesota )
UMN-WCC-34 ( Other Identifier: Women's Cancer Center, University of Minnesota )
104864/638 ( Other Identifier: GlaxoSmithKline )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Masonic Cancer Center, University of Minnesota
Study Sponsor  ICMJE Masonic Cancer Center, University of Minnesota
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Study Chair: Linda F. Carson, MD Masonic Cancer Center, University of Minnesota
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP