Status:
COMPLETED
Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Esophageal Cancer
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
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 advan...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00072332
Start Date
August 1 2003
End Date
December 1 2009
Last Update
December 19 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021