Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
Esophageal Cancer, Gastric Cancer, Unspecified Adult Solid Tumor, Protocol Specific
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring unspecified adult solid tumor, protocol specific, stage IV esophageal cancer, stage IV gastric cancer
Eligibility 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
Sites / Locations
- Memorial Sloan-Kettering Cancer Center