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Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors Clinical research trials and Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors healthcare trials occur in a lot of 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 generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors. Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors clinical trial. Test subjects typically receive the most effective healthcare possible for their Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors  Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
For Condition: stage 4 esophageal cancer,stage 4 gastric cancer,unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as edotecarin and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining edotecarin with cisplatin may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining edotecarin with cisplatin in treating patients who have advanced or metastaticsolid tumors.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose and recommended phase II dose of edotecarin when administered with cisplatin (administered in 2 different schedules) in patients with advanced or metastatic solid tumors. Secondary - Determine the safety profile of this regimen in these patients. - Determine the plasma pharmacokinetics of this regimen in these patients. - Determine the antitumor activity of this regimen in these patients. OUTLINE: This is an open-label, multicenter, dose-escalation study of edotecarin. Patients are assigned to 1 of 2 schedules. - Schedule A: Patients receive cisplatin IV over 30 minutes and edotecarin IV over 1 hour on days 1 and 8. - Schedule B: Patients receive cisplatin IV over 2 hours and edotecarin IV over 1 hour on day 1. In both schedules, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients in each schedule receive escalating doses of edotecarin 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. Once the MTD is determined, 10 additional patients with metastatic esophageal or gastric cancer receive treatment as above at the MTD. Patients are followed every 2 months for 1 year or until disease progression. PROJECTED ACCRUAL: A maximum of 80 patients (40 per schedule) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of one of the following: - Histologically or cytologically confirmed active solid tumor malignancy - Histologically confirmed esophageal or gastric cancer* meeting all the following criteria: - Previously untreated disease - Metastatic disease - Measurable disease - At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR 10 mm by spiral CT scan NOTE: *Patients with esophageal or gastric cancer are enrolled after the maximum tolerated dose has been determined - No known brain or leptomeningeal disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9.0 g/dL Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) (regardless of liver involvement by tumor) - SGOT no greater than 3 times ULN (5 times ULN if there is liver involvement by tumor) - Albumin at least 3.0 g/dL Renal - Creatinine no greater than 1.5 mg/dL Cardiovascular - None of the following within the past 12 months: - Myocardial infarction - Severe/unstable angina - Symptomatic congestive heart failure - Cerebrovascular accident - Transient ischemic attack - Deep vein thrombosis - Other significant thromboembolic event - No ongoing grade 2 or greater cardiac dysrhythmia - No atrial fibrillation Pulmonary - No pulmonary embolism within the past 12 months Gastrointestinal - No active inflammatory bowel disease - No partial or complete bowel obstruction - No chronic diarrhea Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No grade 2 or greater acute toxic effects - No active infection - No other concurrent acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No prior treatment with any of the following systemic therapies for metastatic cancer*: - Antibody therapy - Immunotherapy - Gene therapy - Vaccine therapy - Cytokine therapy - Inhibitors of vascular endothelial growth factor/Flk-1 pathway - No concurrent sargramostim (GM-CSF) - No concurrent antibody therapy or immunotherapy NOTE: *Patients with esophageal or gastric cancer only Chemotherapy - No more than 1 prior chemotherapy regimen for metastatic disease* - No prior high-dose chemotherapy requiring hematopoietic stem cell rescue - No other concurrent chemotherapy NOTE: *No prior chemotherapy for metastatic disease for patients with esophageal or gastric cancer Endocrine therapy - No concurrent hormonal treatment Radiotherapy - No prior radiotherapy to more than 25% of bone marrow reserve - No prior radiotherapy to the sole measurable lesion* - No concurrent radiotherapy NOTE: *Patients with esophageal or gastric cancer only Surgery - More than 12 months since prior coronary/peripheral artery bypass graft surgery Other - Recovered from prior therapy - More than 6 months since last dose of prior adjuvant therapy* - No prior treatment with any of the following systemic therapies for metastatic cancer*: - Cyclooxygenase-2 inhibitors - Matrix metalloprotease inhibitors - Epidermal growth factor receptor inhibitors - Other experimental agents - No other concurrent anticancer therapy - No concurrent enrollment in another clinical trial - No other concurrent experimental drugs NOTE: *Patients with esophageal or gastric cancer only
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidIlson, Principal Investigator, 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: CDR0000339607; PHARMACIA-EDOAES-2730-001,MSKCC-03070
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072332
Other Stage 4 Esophageal Cancer Studies:
1. Topotecan and Bortezomib in Treating Patients With Metastatic or Unresectable Cancer
2. Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Solid Tumors
3. Gefitinib, Capecitabine, and Celecoxib in Treating Patients With Advanced Solid Tumors
4. DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer
5. LY293111 in Treating Patients With Advanced Solid Tumors
Related Studies:
Other stage 4 esophageal cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
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