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 biliary cancer.

Condition	Treatment or Intervention	Phase
localized gallbladder cancer cholangiocarcinoma of the gallbladder localized extrahepatic bile duct cancer recurrent gallbladder cancer unresectable gallbladder cancer cholangiocarcinoma of the extrahepatic bile duct liver and intrahepatic biliary tract cancer adult primary cholangiocellular carcinoma recurrent extrahepatic bile duct cancer unresectable extrahepatic bile duct cancer	Drug: exatecan mesylate	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the antitumor activity of DX-8951f in terms of antitumor response, response duration, and survival in patients with biliary tree cancer. II. Evaluate the quantitative and qualitative toxicities of this treatment regimen in this patient population. III. Evaluate the pharmacokinetics of DX-8951 in plasma.

PROTOCOL OUTLINE: Patients receive DX-8951f IV over 30 minutes daily for 5 days. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12 months.

Ages Eligible for Study:  16 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed cholangiocarcinoma, bile duct cancer, or gallbladder cancer with or without evidence of unresectable extrahepatic metastasis; Previously untreated disease OR Progressive disease after first line chemotherapy
• Bidimensionally measurable disease by CT scan, chest x-ray, or MRI of the abdomen
• No known brain metastases

--Prior/Concurrent Therapy--

• Biologic therapy: No concurrent biologic therapy
• Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy and recovered; No prior camptothecin analogues; No other concurrent chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: 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 therapy; At least 4 weeks since prior investigational drugs; No other investigational drugs during or within 4 weeks after final dose of study drug; No concurrent drugs that induce or inhibit CYP3A enzyme

--Patient Characteristics--

• Age: 16 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; Hemoglobin at least 9.0 g/dL
• Hepatic: Bilirubin no greater than 2.0 mg/dL; Albumin at least 2.8 g/dL; SGOT or SGPT no greater than 5 times upper limit of normal (ULN); PT or INR no greater than 1.5 times ULN (if not on Coumadin therapy)
• 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 before and during study; No concurrent serious infection; No other life threatening illness; No overt psychosis or mental disability that would preclude informed consent; No other malignancy within the past 5 years, except: Curatively treated nonmelanomatous skin cancer; Carcinoma in situ of the cervix

Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80262,  United States
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
Texas
      Cancer Therapy & Research Center, San Antonio,  Texas,  78229,  United States
      Simmons Cancer Center - Dallas, Dallas,  Texas,  75235-9154,  United States
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Robert L. DeJager,  Study Chair,  Daiichi Pharmaceuticals   

Study ID Numbers:  CDR0000067736; DAIICHI-8951A-PRT020; MDA-ID-99379; MSKCC-99110; SACI-IDD-99-31; UCHSC-00892; UTHSC-9905011256
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00005938
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08