Clinical Trial: Gemcitabine Plus High-Dose 5-Fu/Leucovorin in the Treatment of Advanced or Metastatic Carcinoma of the Biliary Tract

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Phase II Randomized Trial-Weekly Gemcitabine Plus High-Dose 5-Fluorouracil/ Leucovorin in the Treatment of Advanced or Metastatic Carcinoma of the Biliary Tract

Brief Summary: This is an open-label phase II trial with weekly gemcitabine plus high-dose 5-FU/leucovorin infusion (HDFL) for patients with advanced or metastatic carcinoma of the biliary tract. The primary endpoint is patients' response and the secondary endpoints are chemotherapy-related toxicity, time to disease progression and overall survival. .

Detailed Summary:

5-FU has been the mainstay of chemotherapeutic agents for gastrointestinal malignancies. The use of weekly 24-hour infusion of HDFL produces high clinical response in a variety of cancers, including colorectal, gastric and breast cancers, with minimal chemotherapy-related toxicity. Gemcitabine is a synthesized deoxycytidine analogue that is metabolized to dFdCTP in tumor cells and results in inhibition of DNA synthesis and depletion of normal cellular nucleotide pool. It has been shown to be active in the treatment of pancreatic cancer and non-small cell lung cancer. Since the biliary tract and the pancreas share a common embryonic origin and cancers from both sites are characterized by resistance to most chemotherapeutic agents, we postulate that gemcitabine may also be effective for cancer of the biliary tract. In our institution we have devised a regimen of weekly gemcitabine and 24-hour infusion of HDFL for patients with advanced or metastatic pancreatic adenocarcinoma. In 18 evaluable patients, 2 achieved a partial response and 3 minor response. The median duration of response was 4 months and the treatment-related toxicity was acceptable.

The eligibility criteria are patients with advanced or metastatic carcinoma of the biliary tract who are not candidates for curative surgical treatment; good performance status; no prior chemotherapy; clinical measurable tumor; good organ function and good compliance. Each cycle of chemotherapy consists of 4 weeks. On days 1, 8 and 15, gemcitabine will be given by 30-minute intravenous infusion and 5-FU and leucovorin by 24-hour continuous intravenous infusion. The dose of gemcitabine will be 1000 mg/m2. The doses of 5-FU will be 2000 mg/m2 and leucovorin, 300 mg/m2. Treatment will continue until disease progresses or prohibitive toxicity develops. For patients with complete response (CR), chemotherapy will continue for 3 additiona
Sponsor: National Health Research Institutes, Taiwan

Current Primary Outcome: To determine the response rate of weekly gemcitabine plus high-dose 5-FU/leucovorin chemotherapy for patients with advanced or metastatic biliary tract cancer.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To determine:
  • 1.Toxicity profile of gemcitabine plus high-dose 5-FU/leucovorin chemotherapy for advanced or metastatic biliary tract cancer.
  • 2.Time to disease progression
  • 3.Overall survival
  • 4.Quality of life


Original Secondary Outcome: Same as current

Information By: National Health Research Institutes, Taiwan

Dates:
Date Received: September 13, 2005
Date Started: July 2002
Date Completion: August 2012
Last Updated: March 30, 2009
Last Verified: September 2005