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Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus Clinical research trials and Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus clinical trial. Participants frequently get the best healthcare available for their Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus  Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
For Condition: stage 3 esophageal cancer,stage 2 esophageal cancer,Adenocarcinoma of the Esophagus,squamous cell carcinoma of the esophagus,stage 4 esophageal cancer
Status: No longer recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining irinotecan and cisplatin in treating patients who have locally advanced unresectable or metastatic cancer of the esophagus that has not been previously treated.
Details: OBJECTIVES: - Determine the objective tumor response rate in patients with previously untreated locally advanced unresectable or metastatic esophageal cancer treated with irinotecan and cisplatin. - Determine the dysphagia relief in patients treated with this regimen. - Determine the time to progression and overall survival of patients treated with this regimen. - Determine the safety of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive cisplatin IV over 1-2 hours and irinotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus - Previously untreated - Locally advanced unresectable or metastatic disease - More than 50% of tumor must involve esophagus or gastroesophageal (GE) junction if tumor extends below the GE junction into the proximal stomach - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR - At least 10 mm by spiral CT scan - The following are not considered measurable disease: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusions - Lymphangitis cutis/pulmonis - Abdominal masses not confirmed and followed by imaging techniques - Cystic lesions - Tumor lesions in previously irradiated areas - No carcinomatous meningitis or untreated brain metastases - Brain metastases allowed if asymptomatic and patient is on stable or tapering dose of steroids - Large pleural effusions must have been previously drained and sclerosed or otherwise controlled - Small, stable, asymptomatic pleural effusions allowed - Dysphagia allowed PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - At least 3 months Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present) - No known Gilbert's disease Renal: - Creatinine no greater than 1.5 mg/dL - Calcium less than 12.0 mg/dL Cardiovascular: - No history of significant cardiovascular disease - No inadequately controlled hypertension - No unstable angina - No myocardial infarction within the past 6 months - No ventricular cardiac arrhythmias requiring medication - No history or treatment for congestive heart failure Pulmonary: - No interstitial pneumonia - No fibroid lung Other: - No serious active infection - No uncontrolled diabetes mellitus (random blood sugar at least 300 mg) - No peripheral neuropathy grade 2 or greater - No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other malignancy that does not carry a worse prognosis than advanced esophageal cancer - No other serious underlying medical condition that would preclude study - No other concurrent disease that would preclude study - No psychiatric illness or other significant mental impairment that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - See Disease Characteristics Radiotherapy: - See Disease Characteristics - At least 2 weeks since prior radiotherapy and recovered - No prior radiotherapy to the pelvis Surgery: - See Disease Characteristics - Not specified Other: - No concurrent phenytoin or phenobarbital
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidIlson, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000069204; MSKCC-01123,PHARMACIA-440E-ONC-0020-319,NCI-G01-2050
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030862
Other Adenocarcinoma Of The Esophagus Studies:
1. Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer
2. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer
3. Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer
4. Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus
5. Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus
Related Studies:
Other Adenocarcinoma of the Esophagus Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
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