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Status:

COMPLETED

Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer

Lead Sponsor:

Gynecologic Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Cervical Adenocarcinoma

Cervical Adenosquamous Carcinoma

Eligibility:

FEMALE

18+ years

Phase:

PHASE1

Brief Summary

This phase I trial is studying the side effects and best dose of cetuximab when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IV...

Detailed Description

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose or safe biologically effective dose of cetuximab when administered in combination with cisplatin, external beam radiotherapy, and brachythe...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically confirmed cervical cancer
  • Clinical stage IB-IVA disease
  • Any cell type allowed
  • Positive or negative pelvic and/or para-aortic lymph nodes by radiography
  • Unstained sections from primary tumor available
  • Performance status - GOG 0-1
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Creatinine normal
  • Creatinine clearance \> 50 mL/min
  • Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry
  • No renal abnormality (e.g., pelvic kidney or horseshoe kidney) that would require modification of radiation fields
  • No significant cardiac disease within the past 6 months, including any of the following:
  • Uncontrolled hypertension
  • Unstable angina
  • Congestive heart failure
  • Uncontrolled arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No sensory or motor neuropathy \> grade 1
  • No septicemia
  • No severe infection
  • No circumstance that would preclude study participation or follow-up
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No uncontrolled seizure disorder
  • No active neurologic disease
  • No history of active collagen vascular disease
  • No prior chimerized or murine monoclonal antibody therapy
  • No prior cytotoxic chemotherapy for cervical cancer
  • No prior pelvic or abdominal radiotherapy for cervical cancer
  • No concurrent intensity modulated radiotherapy
  • No prior renal transplantation
  • More than 30 days since prior major surgery (excluding diagnostic biopsy)
  • No other prior therapy for cervical cancer
  • No prior cancer treatment that would preclude study therapy
  • No other concurrent investigational agents

Exclusion

    Key Trial Info

    Start Date :

    January 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    64 Patients enrolled

    Trial Details

    Trial ID

    NCT00104910

    Start Date

    January 1 2005

    Last Update

    December 31 2014

    Active Locations (15)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (15 locations)

    1

    Georgia Regents University Medical Center

    Augusta, Georgia, United States, 30912

    2

    University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, United States, 60637

    3

    Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, United States, 46202

    4

    University of Iowa Hospitals and Clinics

    Iowa City, Iowa, United States, 52242