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

NCT00639769 | Completed Phase 2 Results DMC

• 3 other identifiers: VICC HN 0164VU-VICC-HN-0164VU-VICC-01-0847
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 8

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks after last chemotherapy treatment

Secondary Outcomes (1)

• Number of Patients With Each Worst-grade Toxicity

  6 weeks after last chemotherapy

Study Arms (1)

Therapeutic Intervention

EXPERIMENTAL

Drug: cisplatin; Drug: irinotecan hydrochloride

Interventions

cisplatin DRUG

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

Also known as: Platinol,Platinol-AQ,cisdamminedichloroplatinum(II),kCDDP,DDP,DACP,cisplatinum,platinum

Therapeutic Intervention

irinotecan hydrochloride 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.

Also known as: CPT-11

Therapeutic Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (8)

Central Georgia Hematology Oncology Associates, P.C.

Macon, Georgia, United States

Location

Erlanger Health System

Chattanooga, Tennessee, United States

Location

Jackson-Madison County Hospital

Jackson, Tennessee, United States

Location

East Tennessee State University

Johnson City, Tennessee, United States

Location

Center for Biomedical Research

Knoxville, Tennessee, United States

Location

Meharry Medical College

Nashville, Tennessee, United States

Location

VA Tennessee Valley Healthcare Center

Nashville, Tennessee, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Location

Related Publications (1)

• 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.

  PMID: 18484593 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Salivary Gland Neoplasms

Interventions

Cisplatin; Irinotecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Barbara Murphy, M.D.
• Organization: Vanderbilt-Ingram Cancer Center

barbara.murphy@vanderbilt.edu

Study Officials

• Barbara A. Murphy, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 20, 2008
• Study Start: February 1, 2002
• Primary Completion: May 1, 2007
• Study Completion: July 1, 2008
• Last Updated: September 14, 2012
• Results First Posted: December 7, 2011

Record last verified: 2012-09

Locations

US (8)