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Sponsored by: |
Daiichi Sankyo Inc. |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003951 |
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 DX-8951f in treating patients who have metastatic cancer of the pancreas that has not been previously treated or that has not responded to previous chemotherapy.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Drug: exatecan mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Metastatic Carcinoma of the Pancreas |
Estimated Enrollment: | 37 |
Study Start Date: | June 1999 |
OBJECTIVES: I. Determine the objective response rate in patients with metastatic carcinoma of the exocrine pancreas treated with DX-8951f. II. Determine the time to tumor progression in patients receiving this drug. III.
Determine the survival at 6 and 12 months of patients receiving this drug. IV. Evaluate the quantitative and qualitative toxicities of this regimen in this patient population. V. Evaluate the pharmacokinetics of this drug in this patient population.
OUTLINE: Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed epithelial cancer of the exocrine pancreas Metastatic disease Previously untreated disease or progressive disease after first-line chemotherapy Bidimensionally measurable disease Indicator lesion must be outside of any prior radiation port No brain metastases No islet cell tumors, lymphoma, or sarcoma of the pancreas
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks
Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic:
Bilirubin no greater than 1.5 mg/dL SGOT/SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled angina No myocardial infarction within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent serious infection No history of other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No overt psychosis, mental disability, or incompetence No other life threatening illness
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy No prophylactic colony stimulating factors to prevent neutropenia Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No other concurrent cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered No concurrent surgery Other: No other concurrent anticancer treatment At least 28 days since other prior investigational drugs, including analgesics or antiemetics No other investigational drugs during and for 28 days after study No concurrent drugs that induce or inhibit CYP3A enzyme
United States, Maryland | |
Johns Hopkins Oncology Center | |
Baltimore, Maryland, United States, 21287 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, Texas | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78284 |
Study Chair: | Robert L. DeJager, MD, FACP | Daiichi Sankyo Inc. |
Study ID Numbers: | CDR0000067147, DAIICHI-8951A-PRT009, JHOC-99062405, MSKCC-99014 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003951 History of Changes |
Health Authority: | United States: Federal Government |
recurrent pancreatic cancer duct cell adenocarcinoma of the pancreas stage IV pancreatic cancer |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases DX 8951 Pancrelipase Recurrence Carcinoma Digestive System Diseases |
Neoplasm Metastasis Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Gastrointestinal Agents Endocrine System Diseases Enzyme Inhibitors DX 8951 Pancrelipase |
Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Pancreatic Diseases Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |