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Sponsored by: |
Daiichi Sankyo Inc. |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00017212 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have metastatic stomach cancer.
Condition | Intervention | Phase |
---|---|---|
Esophageal Cancer Gastric Cancer |
Drug: exatecan mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study Of Intravenous Exatecan Mesylate (DX-891F) Administered Daily For Five Days Every Three Weeks To Patients With Previously Untreated Metastatic Gastric Cancer |
Study Start Date: | April 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive exatecan mesylate (DX-8951f) IV over 30 minutes on days 1-5. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed gastric or gastroesophageal adenocarcinoma
Measurable disease with indicator lesions outside the field of prior radiotherapy
Nonmeasurable lesions include the following:
No prior treatment for locally advanced or metastatic disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
Pacific Shores Medical Group | |
Long Beach, California, United States, 90813 | |
United States, Colorado | |
Rocky Mountain Cancer Centers | |
Denver, Colorado, United States, 80218 | |
United States, Texas | |
Cancer Therapy and Research Center | |
San Antonio, Texas, United States, 78229-3264 | |
Simmons Cancer Center - Dallas | |
Dallas, Texas, United States, 75235-9154 | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 | |
Canada, Ontario | |
Cancer Care Ontario-Hamilton Regional Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 |
Study Chair: | Robert L. DeJager, MD, FACP | Daiichi Sankyo Inc. |
Study ID Numbers: | CDR0000068663, DAIICHI-8951A-PRT028, SACI-IDD-00-27, UTHSC-0015011134 |
Study First Received: | June 6, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00017212 |
Health Authority: | United States: Federal Government |
stage III gastric cancer stage IV gastric cancer recurrent gastric cancer stage III esophageal cancer |
stage IV esophageal cancer recurrent esophageal cancer adenocarcinoma of the stomach adenocarcinoma of the esophagus |
Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Esophageal Neoplasms Stomach cancer DX 8951 Camptothecin Recurrence |
Digestive System Diseases Stomach Diseases Stomach Neoplasms Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma Esophageal neoplasm |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |