Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors

NCT00072332 | Completed Phase 1

• 3 other identifiers: CDR0000339607MSKCC-03070PHARMACIA-EDOAES-2730-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining edotecarin with cisplatin in treating patients who have advanced or metastatic solid tumors.

Conditions

Esophageal Cancer; Gastric Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific; stage IV esophageal cancer; stage IV gastric cancer

Interventions

cisplatin DRUG

edotecarin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Interventions

Cisplatin; edotecarin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• David H. Ilson, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 6, 2003
• Study Start: August 1, 2003
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2009
• Last Updated: December 19, 2013

Record last verified: 2009-12

Locations

US (1)