Overview
BMS-247550 Plus Cisplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
National Cancer Institute (NCI)Treatments:
Cisplatin
Criteria
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