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Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer Clinical research trials and Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer. Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer  Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
For Condition: squamous cell carcinoma of the esophagus,recurrent esophageal cancer,stage 4 esophageal cancer,stage 3 esophageal cancer,Adenocarcinoma of the Esophagus
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Erlotinib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have advanced esophageal cancer or stomach cancer.
Details: OBJECTIVES: - Determine the objective response rate in patients with advanced carcinoma of the esophagus or gastroesophageal junction treated with erlotinib. - Determine the overall survival of patients treated with this drug. - Determine the degree of dysphagia relief in patients treated with this drug. - Determine the toxicity and tolerability of this drug in these patients. - Correlate epidermal growth factor receptor (EGFR) expression with response to treatment in these patients. OUTLINE: This is a non-randomized study. Patients are stratified according to epidermal growth factor receptor status (positive vs negative). Patients receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 18-48 patients (9-24 per stratum) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed adenocarcinoma, squamous cell or small cell carcinoma, or carcinoma not otherwise specified of the esophagus or gastroesophageal junction - Metastatic or surgically unresectable disease - Measurable disease outside of primary tumor - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - No bone metastases, abnormal radionuclide bone scans, or pleural effusions as only site of measurable disease - No known brain metastases or carcinomatous meningitis - Must consent to having tumor tissue tested for epidermal growth factor receptor status PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - More than 3 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST no greater than 2 times ULN Renal - Creatinine no greater than 1.5 mg/dL - Calcium no greater than 12 mg/dL - No symptomatic hypercalcemia Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No ventricular arrhythmia Other - No other malignancy within the past 3 years except adequately treated carcinoma in situ of the cervix, superficial transitional cell carcinoma of the bladder, or basal cell or squamous cell skin cancer - No other uncontrolled concurrent illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study participation - No other concurrent disease that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - No prior cetuximab Chemotherapy - No more than 1 prior chemotherapy regimen for advanced or metastatic disease - One prior chemotherapy in the adjuvant setting allowed - Adjuvant chemotherapy must have been administered at least 12 months prior to treatment for advanced or metastatic disease - At least 3 weeks since prior chemotherapy - No concurrent investigational or commercial chemotherapy Endocrine therapy - Not specified Radiotherapy - At least 3 weeks since prior radiotherapy Surgery - Not specified Other - No prior erlotinib-related compounds or compounds of similar biologic or chemical components - No prior EGFR-targeting compounds (e.g., gefitinib) - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidIlson, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting David Ilson 212-639-8306
Additional Information:
Study ID Numbers: CDR0000256601; MSKCC-02035,NCI-5445,NSC-718781
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045526
Other Recurrent Esophageal Cancer Studies:
1. Oxaliplatin With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach
2. Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus
3. Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus
4. Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
5. Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
Related Studies:
Other recurrent esophageal cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
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