Head and Neck Cancer Clinical Trial
Official title:
Phase I/II Trial of the Epothilone B Analogue BMS 247550 (NSC 710428)/Cisplatin in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Phase I/II trial to study the effectiveness of combining BMS-247550 with cisplatin in treating patients who have metastatic or recurrent head and neck cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
Status | Completed |
Enrollment | 27 |
Est. completion date | |
Est. primary completion date | July 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the head and neck considered incurable by surgery or radiotherapy - No nasopharyngeal disease as primary site - Extensive, local-regional or distant metastatic disease - Newly diagnosed OR - Recurrent disease after initial treatment with surgery or radiotherapy (including neoadjuvant chemotherapy or concurrent chemoradiotherapy) - Measurable disease - If only site of measurable disease is in a previously irradiated area, disease progression after radiotherapy must be documented PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Hematopoietic - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 2.0 mg/dL - Transaminases no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver involvement) Renal - Creatinine no greater than 1.5 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No evidence of active infection - No other malignancy within the past 2 years except curatively treated stage 0 or I cancer PRIOR CONCURRENT THERAPY: Chemotherapy - No prior chemotherapy for recurrent disease Radiotherapy - At least 6 months since prior radiotherapy and recovered Surgery - Recovered from prior surgery |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
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