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	Treatment or Intervention	Phase
recurrent pancreatic cancer duct cell adenocarcinoma of the pancreas stage IV pancreatic cancer adenocarcinoma of the pancreas	Drug: DX-8951f	Phase II

Further Study Details: 

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.

PROTOCOL 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 above

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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

--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

Maryland
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21287,  United States
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
Texas
      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78284,  United States

Study chairs or principal investigators

Robert L. DeJager,  Study Chair,  Daiichi Pharmaceuticals   

Study ID Numbers:  CDR0000067147; DAIICHI-8951A-PRT009; JHOC-99062405; MSKCC-99014
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003951
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08