Clinical trial NCT00639769: 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
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-03-20
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Patient Response
timeFrame: 6 weeks after last chemotherapy treatment
Secondary outcomes:
measure: Number of Patients With Each Worst-grade Toxicity
timeFrame: 6 weeks after last chemotherapy
Other outcomes:
Locations:
city: Macon
country: United States
facility: Central Georgia Hematology Oncology Associates, P.C.
state: Georgia
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
city: Jackson
country: United States
facility: Jackson-Madison County Hospital
state: Tennessee
city: Johnson City
country: United States
facility: East Tennessee State University
state: Tennessee
city: Knoxville
country: United States
facility: Center for Biomedical Research
state: Tennessee
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
city: Nashville
country: United States
facility: VA Tennessee Valley Healthcare Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Barbara A. Murphy, MD
role: STUDY_CHAIR
References:
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.