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

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: liposomal lurtotecan

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00022594

EORTC-16008

OSI-EORTC-16008

GILEAD-110-10

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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