Title
Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
Phase II Study Of NX 211 (Liposomal Lurtotecan) Given As An IV Bolus Injection On Days 1 and 8 Every 3 Weeks In Patients With Metastatic Or Loco-Regional Recurrent Squamous Cell Carcinoma Of The Head and Neck With Target Lesions Within Previously Irradiated Fields Or Outside Previously Irradiated Fields
Phase
Phase 2Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Head and Neck CancerIntervention/Treatment
lurtotecan ...Study Participants
50RATIONALE: 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.
OBJECTIVES:
Determine the therapeutic activity of lurtotecan liposome in patients with metastatic or loco-regionally recurrent squamous cell carcinoma of the head and neck.
Determine the objective response, duration of response, and time to progression in patients treated with this drug.
Determine the toxicity profile of this drug in these patients.
Determine the possible pharmacokinetic/pharmacodynamic relationship of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to presence of a target lesion in a previously irradiated field (within vs outside).
Patients receive lurtotecan liposome IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks.
PROJECTED ACCRUAL: A total of 38-72 patients (19-36 per stratum) will be accrued for this study.
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
