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

Vanderbilt University Medical Center

Status and phase

Completed

Phase 2

Conditions

Head and Neck Cancer

Treatments

Drug: cisplatin

Drug: irinotecan hydrochloride

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00639769

VICC HN 0164

VU-VICC-01-0847

VU-VICC-HN-0164

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No 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)