Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of liposomal lurtotecan in treating patients who have metastatic or locally recurrent head and neck cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Camptothecin; Lurtotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the head and neck

• Metastatic or loco-regionally recurrent disease

• No undifferentiated or non-keratinizing carcinomas including lymphoepitheliomas

• No tumors of the nasal or paranasal cavities or of the nasopharynx

• Measurable disease

• No clinical symptomatic evidence of brain or leptomeningeal metastases

• Ineligible for loco-regional treatment after chemotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin less than 1.5 times upper limit of normal (ULN)

• Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present)

Renal:

• Creatinine no greater than 1.5 times ULN

• No uncontrolled hypercalcemia

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 30 days after study

• No known hypersensitivity to systemic liposomal formulations or compounds chemically related to study drug

• No uncontrolled systemic disease or infection

• No psychological, familial, sociological, or geographical condition that would preclude study

• No other prior or concurrent malignancy except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent anticancer biological therapy or immune response modifiers

• No concurrent prophylactic hematopoietic growth factors

Chemotherapy:

• See Disease Characteristics

• No prior chemotherapy for recurrent disease

• No prior therapy with camptothecin analogues

• At least 8 weeks since prior neoadjuvant or adjuvant chemotherapy

• No other concurrent anticancer cytotoxic therapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 8 weeks since prior radiotherapy and recovered

Surgery:

• Not specified

Other:

• At least 30 days since prior experimental drug