Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: cisplatin; irinotecan hydrochloride
Intervention description: Starting dose 30 mg/m2 Dose level -1 20 mg/m2; 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 MeSH terms: Cisplatin; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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.
    

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)