Completed

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

What is being tested

Data Collection

Who is being recruted

Head and Neck Neoplasms

+ Neoplasms

+ Neoplasms by Site

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: May 2001

See protocol details

Summary

Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC

Last updated: January 14, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2001

Actual date on which the first participant was enrolled.

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.

Official TitlePhase 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

NCT00022594

Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC

Last updated: January 14, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Head and Neck NeoplasmsNeoplasmsNeoplasms by Site

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 20 locations

Suspended

Kaiser Franz Josef Hospital

Vienna (Wien), AustriaSee the location

Suspended

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Suspended

Centre Jean Perrin

Clermont-Ferrand, France

Suspended

Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

Dijon, France

Completed20 Study Centers