Completed

A Phase I Dose Escalation Study of Edotecarin (PHA-782615) and Cisplatin in Adult Patients With Advanced/Metastatic Solid Tumors

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What is being tested

Data Collection

Who is being recruted

Digestive System Diseases
+8

+ Digestive System Neoplasms
+ Esophageal Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: August 2003
See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2003Actual date on which the first participant was enrolled.

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.

Official TitleA Phase I Dose Escalation Study of Edotecarin (PHA-782615) and Cisplatin in Adult Patients With Advanced/Metastatic Solid Tumors 
NCT00072332
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases
Stomach Neoplasms
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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Memorial Sloan-Kettering Cancer CenterNew York, United StatesSee the location

CompletedOne Study Center
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