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

July 8, 2010 updated by: Medical University Innsbruck

A Two-Stage Multicenter Phase II Trial of Concurrent Panitumumab Immunotherapy, Cisplatin Chemotherapy and Pelvic Radiotherapy for Primary Cancer of the Uterine Cervix Stage IB-IIIB

RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as 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. Giving panitumumab and cisplatin together with pelvic radiation therapy may be effective in treating patients with cervical cancer.

PURPOSE: This phase II trial is studying the side effects of giving panitumumab and cisplatin together with pelvic radiation therapy in treating patients with stage IB, stage II, or stage III cervical cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To assess the activity of concurrent panitumumab and cisplatin chemoradiotherapy in patients with stage IB-IIIB, KRAS-wild type (KRAS^wt) cervical cancer, in terms of progression-free survival at 4 months by MRI according to RECIST criteria.
  • To assess the rate of skin toxicity (e.g., photosensitivity, acneiform rash, and dermatitis) CTCAE grade 4 and/or gastrointestinal toxicity (comprising all grades of gastrointestinal perforation; leakage of stomach, small intestine, colon, rectum, or elsewhere in the peritoneal cavity occurring after the first application of study treatment and not immediately related to a surgical procedure) at 4 months, of this regimen in these patients.

Secondary

  • To assess the activity of this regimen in KRAS^wt-positive and -negative patients, in terms of overall response rate at 4 months.
  • To assess the activity of this regimen in KRAS^wt-positive and -negative patients, in terms of progression-free survival at 12 months and 24 months.
  • To assess the activity of this regimen in KRAS^wt-positive and -negative patients, in terms of overall survival at 12 months and 24 months.
  • To assess the rate of severe adverse events of this regimen in patients with KRAS^wt and KRAS-mutant gene status at 4 months.
  • To assess the rate of post-treatment severe adverse events at 12 months and 24 months.
  • To assess the rate of severe adverse events of panitumumab monotherapy at day 14.

OUTLINE: This is a multicenter study.

Patients receive panitumumab IV on days 1, 14, 29, and 43 and cisplatin IV on days 14, 22, 29, 36, 43, and 50 in the absence of disease progression or unacceptable toxicity. Patients undergo concurrent external-beam and intracavitary radiotherapy (teletherapy of pelvis or high-dose rate brachytherapy) according to treating center specific standards.

Blood and tissue specimens are collected periodically for laboratory analysis.

After completion of study treatment, patients are followed periodically for up to 2 years.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, A-6020
        • Recruiting
        • Innsbruck Universitaetsklinik
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed cervical cancer, including the following subtypes:

    • Squamous small-cell or large-cell carcinoma
    • Adenosquamous cell carcinoma
    • Adenocarcinoma
    • Keratinizing or non-keratinizing carcinoma
  • Stage IB-IIIB disease
  • No para-aortic lymph node metastases or clinical indication for para-aortic field irradiation
  • No predominant and clinically effective neuroendocrine tumor cell differentiation

PATIENT CHARACTERISTICS:

  • WH0 performance status 0-2
  • Serum creatinine clearance > 50 mL/min
  • No other prior or current malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in-situ of the cervix
  • No acute life-threatening vaginal hemorrhage (requiring emergency irradiation or RBC transfusion)

PRIOR CONCURRENT THERAPY:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival at 4 months by MRI according to RECIST criteria
Rate of skin and/or gastrointestinal toxicity CTCAE grade 4 at 4 months

Secondary Outcome Measures

Outcome Measure
Overall response rate at 4 months according to RECIST criteria
Progression-free survival at 12 and 24 months according to RECIST criteria
Overall survival at 12 and 24 months
Rate of severe adverse events according to CTCAE at 4 months
Rate of post-treatment severe adverse events according to CTCAE at 12 and 24 months
Rate of severe adverse events according to CTCAE of panitumumab monotherapy at day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Investigators

  • Principal Investigator: Alain Zeimet, Medical University Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

July 7, 2010

First Submitted That Met QC Criteria

July 7, 2010

First Posted (Estimate)

July 8, 2010

Study Record Updates

Last Update Posted (Estimate)

July 9, 2010

Last Update Submitted That Met QC Criteria

July 8, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000675699
  • MUI-AGO-20
  • EUDRACT-2009-012453-38
  • EU-21043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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