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

European Organisation for Research and Treatment of Cancer - EORTC50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Head and Neck Cancer

Interventions

liposomal lurtotecanDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Kaiser Franz Josef Hospital

Vienna (Wien), Austria

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Data from ClinicalTrials.gov

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