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Neoadjuvant Irinotecan and Cisplatin Followed By Surgical Resection in Treating Patients With Locally Advanced Cancer of the Stomach or Gastroesophageal Junction 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 Neoadjuvant Irinotecan and Cisplatin Followed By Surgical Resection in Treating Patients With Locally Advanced Cancer of the Stomach or Gastroesophageal Junction conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Neoadjuvant Irinotecan and Cisplatin Followed By Surgical Resection in Treating Patients With Locally Advanced Cancer of the Stomach or Gastroesophageal Junction Clinical research trials and Neoadjuvant Irinotecan and Cisplatin Followed By Surgical Resection in Treating Patients With Locally Advanced Cancer of the Stomach or Gastroesophageal Junction 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 Neoadjuvant Irinotecan and Cisplatin Followed By Surgical Resection in Treating Patients With Locally Advanced Cancer of the Stomach or Gastroesophageal Junction. Neoadjuvant Irinotecan and Cisplatin Followed By Surgical Resection in Treating Patients With Locally Advanced Cancer of the Stomach or Gastroesophageal Junction 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 Neoadjuvant Irinotecan and Cisplatin Followed By Surgical Resection in Treating Patients With Locally Advanced Cancer of the Stomach or Gastroesophageal Junction clinical trial. Participants typically obtain the most effective healthcare available for their Neoadjuvant Irinotecan and Cisplatin Followed By Surgical Resection in Treating Patients With Locally Advanced Cancer of the Stomach or Gastroesophageal Junction 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 > "N" Clinical Trials Conditions > Neoadjuvant Irinotecan and Cisplatin Followed By Surgical Resection in Treating Patients With Locally Advanced Cancer of the Stomach or Gastroesophageal Junction  Neoadjuvant Irinotecan and Cisplatin Followed By Surgical Resection in Treating Patients With Locally Advanced Cancer of the Stomach or Gastroesophageal Junction
Neoadjuvant Irinotecan and Cisplatin Followed By Surgical Resection in Treating Patients With Locally Advanced Cancer of the Stomach or Gastroesophageal Junction
For Condition: stage 3 gastric cancer,adenocarcinoma of the stomach,stage 2 gastric cancer,stage 4 gastric cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them before surgery may shrink the tumor so that is can be removed during surgery. PURPOSE: Phase II trial to study the effectiveness of combining neoadjuvant irinotecan with cisplatin in treating patients who are undergoing surgical resection for locally advanced cancer of the stomach or gastroesophageal junction.
Details: OBJECTIVES: - Correlate the early-treatment fludeoxyglucose F 18 (FDG) positron emission tomography response with histologic response and patient outcome, in terms of overall and progression-free survival, in patients with locally advanced adenocarcinoma of the stomach or gastroesophageal junction treated with neoadjuvant irinotecan and cisplatin followed by surgical resection. - Determine the efficacy and safety of this regimen in these patients. - Evaluate the biology of locally advanced gastric cancer and response to chemotherapy by DNA microarray and histopathology in these patients. OUTLINE: This is an open-label, nonrandomized, multicenter study. - Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. - Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection. Patients undergo fludeoxyglucose F 18 (FDG) positron emission tomography (FDG-PET) or CT scan at baseline. Some patients undergo additional FDG-PET/CT scans at weeks 3 and 6. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 10 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the stomach or gastroesophageal (GE) junction - Tumors involving the GE junction must have the bulk of disease in the stomach - Tumors of the distal esophagus that extend less than 2 cm into the stomach are ineligible - Locally advanced disease that is potentially curable by surgery - Any T, N+, M0 or T3-T4, any N, M0 by staging CT scan and laparoscopy or endoscopic ultrasound - No T1-T2, N0, M0 tumors - No metastatic disease - Any suspected sites of M1 disease must be proven to be M0 PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% OR - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 mg/dL Renal - Creatinine no greater than 1.5 mg/dL Cardiovascular - No history of active angina - No New York Heart Association class III or IV heart disease - No myocardial infarction within the past 6 months - No history of significant ventricular arrhythmia requiring antiarrhythmic medication - No history of clinically significant conduction system abnormality Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No concurrent serious infection - No other uncontrolled medical illness that would preclude study participation - No psychiatric illness that would preclude study compliance - No clinically significant auditory impairment - No pre-existing peripheral neuropathy grade 2 or greater - No other active malignancy within the past 5 years except nonmelanoma skin cancer, nonmetastatic prostate cancer, or carcinoma in situ of the cervix - Able to tolerate the proposed study surgical procedure and chemotherapy regimen PRIOR CONCURRENT THERAPY: Biologic therapy - No prior biologic therapy for this disease Chemotherapy - No prior chemotherapy for this disease - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy for this disease Surgery - See Disease Characteristics Other - No concurrent vitamins, antioxidants, or herbal preparations or supplements - A single daily multivitamin tablet is allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ManishShah, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Daniel Coit 212-639-6325
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting Jonathan Cheng 215-728-7083
Additional Information:
Study ID Numbers: CDR0000304738; NCI-5917,MSKCC-03032
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062374
Other Stage 4 Gastric Cancer Studies:
1. Aminocamptothecin in Treating Patients With Stomach Cancer or Cancer of the Esophagus
2. Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer
3. Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors
4. Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach
5. DX-8951f in Treating Patients With Metastatic Stomach Cancer
Related Studies:
Other stage 4 gastric cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Neoadjuvant Irinotecan and Cisplatin Followed By Surgical Resection in Treating Patients With Locally Advanced Cancer of the Stomach or Gastroesophageal Junction
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