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Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer Clinical research trials and Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer. Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "L" Clinical Trials Conditions > Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
For Condition: Neck Cancer,Oral Cancer,Throat Cancer
Status: No longer recruiting
Sponsor(s): European Organization for Research and Treatment of Cancer ,
Synopsis: 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.
Details: OBJECTIVES: I. Determine the therapeutic activity of lurtotecan liposome in patients with metastatic or loco-regionally recurrent squamous cell carcinoma of the head and neck. II. Determine the objective response, duration of response, and time to progression in patients treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Determine the possible pharmacokinetic/pharmacodynamic relationship of this drug in these patients. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: - Neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FlorenceDuffaud, Study Chair, European Organization for Research and Treatment of Cancer
Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa
Lisbon, , 1099-023 Codex
Portugal
Centre Henri Becquerel
Rouen, , 76038
France
Centre Hospitalier Universitaire Vaudois
Lausanne, , CH-1011
Switzerland
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, , 80131
Italy
Kaiser Franz Josef Hospital
Vienna (Wien), , A-1100
Austria
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
Hospital Universitario 12 de Octubre
Madrid, , 28041
Spain
Medizinische Hochschule Hannover
Hannover, , D-30625
Germany
CHU Pitie-Salpetriere
Paris, , 75651
France
CHU de la Timone
Marseille, , 13385
France
Antoni van Leeuwenhoekhuis
Amsterdam, , 1066 CX
Netherlands
Royal Marsden NHS Trust
London, England, SW3 6JJ
United Kingdom
Inselspital, Bern
BERN, , CH-3010
Switzerland
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Centre Jean Perrin
Clermont-Ferrand, , 63011
France
Istituti Fisioterapici Ospitalieri - Roma
Rome, , 00161
Italy
Universitats-Krankenhaus Eppendorf
Hamburg, , D-20246
Germany
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Centre Oscar Lambret
Lille, , 59020
France
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Dijon, , 21079
France
Additional Information:
Study ID Numbers: CDR0000068833; GILEAD-110-10,OSI-EORTC-16008,EORTC-16008
Study Start Date: May 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022594
Other Neck Cancer Studies:
1. Radiation Therapy With or Without Epoetin alfa in Treating Patients With Head and Neck Cancer
2. Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
3. Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
4. Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx
5. Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
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Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
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