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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00072332 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer Gastric Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: cisplatin Drug: edotecarin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase I Dose Escalation Study of Edotecarin (PHA-782615) and Cisplatin in Adult Patients With Advanced/Metastatic Solid Tumors |
| Study Start Date: | August 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter, dose-escalation study of edotecarin. Patients are assigned to 1 of 2 schedules.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following:
Histologically confirmed esophageal or gastric cancer* meeting all the following criteria:
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
None of the following within the past 12 months:
Pulmonary
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior treatment with any of the following systemic therapies for metastatic cancer*:
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No prior treatment with any of the following systemic therapies for metastatic cancer*:
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | David H. Ilson, MD, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000339607, MSKCC-03070, PHARMACIA-EDOAES-2730-001 |
| Study First Received: | November 4, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00072332 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific stage IV esophageal cancer stage IV gastric cancer |
|
Digestive System Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Esophageal Cancer Digestive System Diseases Stomach Diseases Radiation-Sensitizing Agents |
Cisplatin Esophageal Disorder Stomach Neoplasms Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Stomach Cancer |
|
Digestive System Neoplasms Gastrointestinal Diseases Antineoplastic Agents Esophageal Neoplasms Physiological Effects of Drugs Pharmacologic Actions Neoplasms Digestive System Diseases Neoplasms by Site |
Stomach Diseases Radiation-Sensitizing Agents Cisplatin Therapeutic Uses Stomach Neoplasms Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases |