Clinical Trial: Study of Gemcitabine and Carboplatin in the Treatment of Metastatic or Recurrent Cholangiocarcinoma/Gallbladder Cancer

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

Official Title: A Phase II Study of Gemcitabine and Carboplatin in the Treatment of Metastatic or Recurrent Cholangiocarcinoma/Gallbladder Cancer

Brief Summary: To determine the activity of gemcitabine combined with carboplatin in the treatment of patients with metastatic or recurrent cholangiocarcinoma or gallbladder cancer.

Detailed Summary:

Due to better non-hematologic toxicity profile, less need for pre- and post chemotherapy hydration, and tolerability as compared to cisplatin, we propose to combine gemcitabine with carboplatin in the treatment of patients with cholangiocarcinoma and gallbladder carcinoma. In lung cancer, available literature suggests that carboplatin is as efficacious as cisplatin.

Several Phase I, II and III studies using gemcitabine with carboplatin have already been done or are currently ongoing. Phase I studies determined the maximum tolerated doses (MTD) of gemcitabine at 800-1250 mg/m2 days 1 and 8 combined with at AUC of 4-5.5, day 1 of a 21-day cycle.

Initial Phase II studies using a 28-day schedule using gemcitabine on days 1,8 and 15 with carboplatin caused severe thrombocytopenia on day 15 precluding day 15 treatment in over 50% of courses. A Spanish Lung Cancer Group conducted a sequential Phase II trial wherein 52% and 30% of the first 33 patients with lung cancer treated using the 28-day schedule were noted to have Grade 4 thrombocytopenia and neutropenia, respectively. Subsequently, the next 56 patients were treated on the 21-day schedule, and despite a higher dose intensity, response rates were equal (45-48%) with less Grade 4 thrombocytopenia (21%) but similar rates of Grade 4 neutropenia (27%).

A randomized Italian Phase II studies have demonstrated that when gemcitabine was given at doses of 1 g/m2 with carboplatin at AUC of 5 mg/mL/min were tolerable and when compared to gemcitabine and cisplatin caused less non-hematologic toxicities. Current Phase III trials in lung cancer utilizes the 21-day schedule with gemcitabine at 1000 mg/m2 on days 1 and 8 and carboplatin at AUC of 5.5.

Therefore, our proposed schedule will be
Sponsor: Washington University School of Medicine

Current Primary Outcome: To determine the response rate and time to failure for patients treated with this regimen [ Time Frame: Every 3 cycles for a maximum of 9 cycles ]

1 cycle = 21 days


Original Primary Outcome: To determine the activity of gemcitabine combined with carboplatin in the treatment of patients with metastatic or recurrent cholangiocarcinoma or gallbladder cancer. [ Time Frame: throughout trial participation ]

Current Secondary Outcome:

  • To describe the toxicities associated with gemcitabine and carboplatin in patients with cholangiocarcinoma or gallbladder cancer. [ Time Frame: 30 days after last dose of study drug ]
  • To assess the clinical benefit, or lack thereof, of chemotherapy on patient's performance status and weight. [ Time Frame: At the end of study treatment ]
  • Time to progression [ Time Frame: Every 3 months until progression ]
  • Survival times [ Time Frame: Every 3 months until patient death ]


Original Secondary Outcome:

  • To describe the toxicities associated with gemcitabine and carboplatin in patients with cholangiocarcinoma or gallbladder cancer. [ Time Frame: throughout trial participation ]
  • To assess the clinical benefit, or lack thereof, of chemotherapy on patient's performance status and weight. [ Time Frame: throughout trial participation ]


Information By: Washington University School of Medicine

Dates:
Date Received: April 11, 2008
Date Started: March 2002
Date Completion:
Last Updated: August 9, 2013
Last Verified: August 2013