|
Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Clinical research trials and Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer. Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "E" Clinical Trials Conditions > Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer  Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
For Condition: Head and Neck Cancer
Status: Recruiting
Sponsor(s): Princess Margaret Hospital , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with cisplatin may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib and cisplatin in treating patients who have recurrent or metastatic head and neck cancer.
Details: OBJECTIVES: - Determine the objective response rate in patients with recurrent or metastatic squamous cell cancer of the head and neck treated with erlotinib and cisplatin. - Determine the stable disease rates, duration of response, progression-free survival, median survival, and overall survival of patients treated with this regimen. - Determine the safety and tolerability of this regimen in these patients. - Determine the relationship between clinical, pharmacokinetic, and pharmacodynamic effects of this regimen in these patients. - Correlate baseline and post-treatment levels of epidermal growth factor receptor, its downstream signaling components, and markers of angiogenesis and apoptosis in tumor and skin biopsies with clinical outcome in patients treated with this regimen. OUTLINE: This is a dose-escalation, multicenter study. Patients receive oral erlotinib once daily on days -6 to 21 for the first course only and cisplatin IV over 60 minutes on day 1. For the second and subsequent courses, patients receive oral erlotinib once daily on days 1-21 and cisplatin as in course 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after 6 courses may continue to receive erlotinib alone until disease progression. Cohorts of 3-6 patients receive escalating doses of erlotinib and cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD. Patients are followed every 3 months. PROJECTED ACCRUAL: A maximum of 43 patients will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the head and neck - All primary sites, including oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, and paranasal sinus - Recurrent, unresectable, and/or metastatic disease - At least 1 measurable lesion - At least 20 mm with conventional techniques OR at least 10 mm with spiral CT scan - Lesions accessible for biopsy - Tumor specimen available for evaluation of epidermal growth factor receptor (EGFR) expression - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - More than 12 weeks Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.25 times upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Gastrointestinal: - No gastrointestinal tract disease resulting in malabsorption - No requirement for IV alimentation - No active peptic ulcer disease - Inability to swallow tablets or silicon-based G-tubes allowed Ophthalmic: - No abnormalities of the cornea based on history (e.g., dry eye syndrome or Sjogren's syndrome) - No congenital abnormality (e.g., Fuch's dystrophy) - No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) - No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 5 years except carcinoma in situ of the cervix, nonmelanoma skin cancer, or second primary squamous cell cancer originating from the head and neck - No grade 2 or greater residual ototoxicity or neuropathy from prior platinum-based therapy - No significant traumatic injury within the past 21 days - No other concurrent uncontrolled illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for recurrent or metastatic disease - Prior platinum-based chemotherapy with radiotherapy or platinum-based induction chemotherapy allowed - At least 6 months since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Chemotherapy - At least 4 weeks since prior radiotherapy (except low-dose, limited-fraction palliative non-myelosuppressive radiotherapy [e.g., involving less than 20% of functioning bone marrow using 800 cGy in 1 fraction or 2,000 cGy in 5 fractions]) and recovered - No prior radiotherapy to target lesion unless there is evidence of disease progression Surgery: - See Disease Characteristics - At least 21 days since prior major surgery - No prior surgical procedure affecting gastrointestinal absorption Other: - No prior EGFR-targeting therapies - No prior investigational agents for recurrent or metastatic disease - No concurrent combination anti-retroviral therapy for HIV infection - No other concurrent investigational agents - No other concurrent anticancer treatment
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ElizabethEisenhauer, Study Chair, Queen's University
Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London, Ontario, N6A 4L6
Canada
Recruiting Eric Winquist 519-685-8640 ext. 53243
Margaret and Charles Juravinski Cancer Centre *Recruiting*
Hamilton, Ontario, L8V 5C2
Canada
Recruiting George Browman 905-387-9495 ext. 63001
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Eric Chen 416-946-2263
Queen's University *Recruiting*
Kingston, Ontario, K7L 3N6
Canada
Recruiting Elizabeth Eisenhauer 613-533-6430
Additional Information:
Study ID Numbers: CDR0000069178; PMH-PHL-002,NCI-5380,CAN-NCIC-IND157
Study Start Date:
Record last reviewed: July 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030576
Other Head And Neck Cancer Studies:
1. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
2. Cisplatin Plus Gemcitabine in Treating Patients With Advanced Squamous Cell Head and Neck Cancer
3. OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer
4. Gene Therapy in Treating Patients With Advanced Head and Neck Cancer
5. Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
Related Studies:
Other Head and Neck Cancer Clinical Trials
Other Ontario Clinical Trials
Other Hamilton Clinical Trials
Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
|
|
|
|
|
|
|
