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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639769
• Other study ID #: VICC HN 0164
• Secondary ID: VU-VICC-HN-0164V
• Status: Completed
• Phase: Phase 2
• First received: March 19, 2008
• Last updated: September 7, 2012
• Start date: February 2002
• Est. completion date: July 2008

Study information

• Verified date: September 2012
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2008
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• cisplatin
Starting dose 30 mg/m2 Dose level -1 20 mg/m2
• 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.

Locations

Country	Name	City	State
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	Central Georgia Hematology Oncology Associates, P.C.	Macon	Georgia
United States	Meharry Medical College	Nashville	Tennessee
United States	VA Tennessee Valley Healthcare Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	6 weeks after last chemotherapy	Yes