Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

September 7, 2012 updated by: Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center

Phase II Trial of Irinotecan Plus Cisplatin in Patients With Recurrent or Metastatic Squamous Carcinoma of the Head and Neck

RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: To determine if CPT-11 given together with cisplatin is effective in treating recurrent or metastatic head and neck cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Evaluate the efficacy of irinotecan hydrochloride and cisplatin in patients with local-regionally recurrent or metastatic squamous cell carcinoma of the head and neck.
  • Evaluate the toxicity of irinotecan hydrochloride and cisplatin in these patients.
  • Determine the palliative effect of irinotecan hydrochloride and cisplatin on head and neck cancer symptoms using the Vanderbilt Cancer Center (VICC) Head and Neck Cancer Symptom Survey.

OUTLINE: Patients receive irinotecan hydrochloride IV over 60 minutes and cisplatin IV on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients complete the Vanderbilt Cancer Center (VICC) Head and Neck Cancer Symptom Survey at baseline, before each course, at the completion of study therapy, and then at each follow-up visit.

After completion of study therapy, patients are followed every 6 weeks for 1 year and then every 3 months thereafter.

Study Type

Interventional

Enrollment (Actual)

41

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

  • United States
    • Georgia
      • Macon, Georgia, United States
        • Central Georgia Hematology Oncology Associates, P.C.
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Erlanger Health System
      • Jackson, Tennessee, United States
        • Jackson-Madison County Hospital
      • Johnson City, Tennessee, United States
        • East Tennessee State University
      • Knoxville, Tennessee, United States
        • Center for Biomedical Research
      • Nashville, Tennessee, United States
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States
        • Meharry Medical College
      • Nashville, Tennessee, United States
        • VA Tennessee Valley Healthcare Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma of the head and neck that is considered incurable with surgery or radiotherapy

  • Meets one of the following criteria:

    • Previously untreated disease

      • Newly diagnosed disease with distant metastases

    • Recurrent or persistent disease

      • Local-regional recurrence/persistence or distant metastases after initial treatment with surgery or radiotherapy

        • No locally advanced unresectable disease that was not previously treated with radiotherapy

  • Bidimensionally measurable disease

    • If the only measurable disease is within the radiotherapy port, there must be biopsy-proven recurrence ≥ 8 weeks after the completion of radiotherapy

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • Creatinine clearance ≥ 50 mL/min
  • SGOT ≤ 3 times upper limit of normal
  • Serum bilirubin < 1.5 mg/dL
  • Granulocytes ≥ 1,500/mm ^3
  • Platelet count > 100,000/mm^3
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No significant detectable infection
  • No co-morbid disease unless under adequate control
  • No other cancer within the past 3 years except basal cell or squamous cell skin cancer or early-stage prostate cancer

Exclusion Criteria:

-Pregnant or lactating women

Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from any prior major surgery

  • No prior chemotherapy for recurrent or metastatic disease

    • Patients who completed neoadjuvant, concurrent, or adjuvant chemotherapy ≥ 3 months prior to recurrence will be considered chemotherapy-naive
    • Patients who completed neoadjuvant, concurrent, or adjuvant chemotherapy < 3 months prior to recurrence will be considered chemotherapy failures
  • No prior therapy with topotecan or irinotecan hydrochloride
  • At least 4 weeks since prior biologic therapy (e.g., interleukin-2, interferon, megestrol acetate)

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
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapeutic Intervention
Drug: cisplatin
Starting dose 30 mg/m2 Dose level -1 20 mg/m2
Other Names:
  • Platinol,Platinol-AQ,cisdamminedichloroplatinum(II),kCDDP,DDP,DACP,cisplatinum,platinum
Drug: irinotecan hydrochloride
50 mg/m2 IV over 60 minutes, plus Cisplatin 30mig/m2 IV, repeated weekly for two weeks. followed by a one-week rest. This 3-week schedule given two times to equal one 6-week cycle. Maximum of 6 cycles.
Other Names:
  • CPT-11

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Response
Time Frame: 6 weeks after last chemotherapy treatment
Number of patients in each response category according to RECIST criteria: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
6 weeks after last chemotherapy treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Each Worst-grade Toxicity
Time Frame: 6 weeks after last chemotherapy
Number of patients with worst-grade toxicity response of each grade (grade 1 to 5) following NCI Common Toxicity Criteria, with grade 1=mild adverse event; 2=moderate adverse event; 3=severe and undesirable adverse event; 4=life-threatening or disabling adverse event; 5=death
6 weeks after last chemotherapy

Collaborators and Investigators

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

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Barbara A. Murphy, MD, Vanderbilt-Ingram Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2002

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 20, 2008

Study Record Updates

Last Update Posted (Estimate)

September 14, 2012

Last Update Submitted That Met QC Criteria

September 7, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC HN 0164
  • VU-VICC-HN-0164
  • VU-VICC-01-0847

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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