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

NCT ID: NCT00639769

Last Updated: 2012-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2008-07-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Therapeutic Intervention

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

Starting dose 30 mg/m2 Dose level -1 20 mg/m2

irinotecan hydrochloride

Intervention Type: DRUG

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.

Interventions

cisplatin

Starting dose 30 mg/m2 Dose level -1 20 mg/m2

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Platinol,Platinol-AQ,cisdamminedichloroplatinum(II),kCDDP,DDP,DACP,cisplatinum,platinum; CPT-11

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Barbara Murphy, MD

Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara A. Murphy, MD

Role: STUDY_CHAIR

Vanderbilt-Ingram Cancer Center

Locations

Central Georgia Hematology Oncology Associates, P.C.

Macon, Georgia, United States

Erlanger Health System

Chattanooga, Tennessee, United States

Jackson-Madison County Hospital

Jackson, Tennessee, United States

East Tennessee State University

Johnson City, Tennessee, United States

Center for Biomedical Research

Knoxville, Tennessee, United States

Meharry Medical College

Nashville, Tennessee, United States

VA Tennessee Valley Healthcare Center

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18484593 (View on PubMed)

Other Identifiers

VU-VICC-HN-0164

Identifier Type: -

Identifier Source: secondary_id

VU-VICC-01-0847

Identifier Type: -

Identifier Source: secondary_id

VICC HN 0164

Identifier Type: -

Identifier Source: org_study_id