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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
irinotecan hydrochloride
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring recurrent squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent verrucous carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, metastatic squamous neck cancer with occult primary squamous cell carcinoma, recurrent metastatic squamous neck cancer with occult primary, untreated metastatic squamous neck cancer with occult primary, recurrent squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent salivary gland cancer, salivary gland squamous cell carcinoma, stage IV salivary gland cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Therapeutic Intervention

Arm Description

Outcomes

Primary Outcome Measures

Patient Response
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.

Secondary Outcome Measures

Number of Patients With Each Worst-grade Toxicity
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

Full Information

First Posted
March 19, 2008
Last Updated
September 7, 2012
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00639769
Brief Title
Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Official Title
Phase II Trial of Irinotecan Plus Cisplatin in Patients With Recurrent or Metastatic Squamous Carcinoma of the Head and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
recurrent squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent verrucous carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, metastatic squamous neck cancer with occult primary squamous cell carcinoma, recurrent metastatic squamous neck cancer with occult primary, untreated metastatic squamous neck cancer with occult primary, recurrent squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent salivary gland cancer, salivary gland squamous cell carcinoma, stage IV salivary gland cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Intervention
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
Platinol,Platinol-AQ,cisdamminedichloroplatinum(II),kCDDP,DDP,DACP,cisplatinum,platinum
Intervention Description
Starting dose 30 mg/m2 Dose level -1 20 mg/m2
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Other Intervention Name(s)
CPT-11
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Response
Description
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.
Time Frame
6 weeks after last chemotherapy treatment
Secondary Outcome Measure Information:
Title
Number of Patients With Each Worst-grade Toxicity
Description
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
Time Frame
6 weeks after last chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara A. Murphy, MD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Central Georgia Hematology Oncology Associates, P.C.
City
Macon
State/Province
Georgia
Country
United States
Facility Name
Erlanger Health System
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Jackson-Madison County Hospital
City
Jackson
State/Province
Tennessee
Country
United States
Facility Name
East Tennessee State University
City
Johnson City
State/Province
Tennessee
Country
United States
Facility Name
Center for Biomedical Research
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
VA Tennessee Valley Healthcare Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18484593
Citation
Gilbert J, Cmelak A, Shyr Y, Netterville J, Burkey BB, Sinard RJ, Yarbrough WG, Chung CH, Aulino JM, Murphy BA. Phase II trial of irinotecan plus cisplatin in patients with recurrent or metastatic squamous carcinoma of the head and neck. Cancer. 2008 Jul 1;113(1):186-92. doi: 10.1002/cncr.23545.
Results Reference
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Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

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