Clinical trial · Interventional
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
NCT00022594CI-TRIAL-00007530completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| liposomal lurtotecan | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTDuffaud F, Borner M, Chollet P, Vermorken JB, Bloch J, Degardin M, Rolland F, Dittrich C, Baron B, Lacombe D, Fumoleau P; EORTC-New Drug Development Group/New Drug Development Program. Phase II study of OSI-211 (liposomal lurtotecan) in patients with metastatic or loco-regional recurrent squamous cell carcinoma of the head and neck. An EORTC New Drug Development Group study. Eur J Cancer. 2004 Dec;40(18):2748-52. doi: 10.1016/j.ejca.2004.08.024. PMID 15571957