Clinical Trial: Gemcitabine, Oxaliplatin, Tarceva &/or Cisplatin in HCC & Biliary Tree Cancers

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Gemcitabine and Cisplatin With Erlotinib in Hepatocellular Carcinoma (HCC) and Biliary Tree Cancer (BTC) (Intra- and Extra-hepatic Cholangiocarcinoma, Bile Duct Cancer, Ad

Brief Summary: This is a single arm phase II trial of Gemcitabine and Oxaliplatin (Gem-Ox) with Erlotinib (Tarceva) for the treatment of hepatocellular carcinoma (HCC) and biliary tree cancer (BTC) patients with platelet counts 100,000/µL. The purpose of this study is to determine the tumor control rate following treatment with GEM-OX combined with Tarceva in patients with HCC. Tumor control rate is defined as the percentage of patients achieving a complete response, partial response, or stable disease at 24 weeks following treatment.

Detailed Summary: The incidence and mortality of HCC has increased in the United States. Promising responses have been observed in HCC patients treated with gemcitabine and cisplatin, inclusing good disease stabilization and progression free survival. Cisplatin-gemcitabine enhances the cytotoxicity of cisplatin by increasing the formation of cytotoxic platinum DNA adducts. Similarly, Oxaliplatin also has DNA cross linkage properties and one could assume that its combination with gemcitabine is likely to potentiate the cytotoxicity of the latter. Erlotinib has also been reported to result in clinical benefit in HCC and BTC patients. Based on these prior findings, we embarked on this phase II protocol of gemcitabine, oxaliplatin, and erlotinib in HCC and BTC patients.
Sponsor: New Mexico Cancer Care Alliance

Current Primary Outcome: Tumor Control Rate [ Time Frame: 24 weeks ]

Original Primary Outcome: To Determine Rate of Tumor Control (CR + PR + SD at 24 Weeks) Following Treatment With Gem-Ox Combined With Erlotinib in Patients With HCC. [ Time Frame: Patients will continue the study treatment until disease progression, unacceptable toxicity, or development of any of the criteria for patient discontinuation ]

Current Secondary Outcome:

• Overall Response Rate [ Time Frame: 24 weeks ]

  Overall response rate is defined as the percentage of patients achieving a complete response (CR) + partial response (PR) at 24 weeks following treatment.

  Response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

• Time to Tumor Progression (TTP) [ Time Frame: 2 years ]
  The time from treatment initiation to disease progression. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
• Median Survival Time (MST) [ Time Frame: 2 years ]
  Survival is defined as the time from treatment initiation to death by any cause
• Toxicity [ Time Frame: Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition. An average of 24 weeks ]
  Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Frequency and severity of adverse events will be tabulated using counts of frequently occurring, serious and severe events of interest (i.e. Grade 3 and Grade 4 adverse events).

Original Secondary Outcome:

• Determine CR + PR Rate. [ Time Frame: Patients will continue the study treatment until disease progression, unacceptable toxicity, or development of any of the criteria for patient discontinuation ]
• To Determine Time to Tumor Progression (TTP) [ Time Frame: Patients will continue the study treatment until disease progression, unacceptable toxicity, or development of any of the criteria for patient discontinuation ]
• To Determine Patient Medial Survival Time (MST) [ Time Frame: Patients will continue the study treatment until disease progression, unacceptable toxicity, or development of any of the criteria for patient discontinuation ]
• To Determine Treatment Related Toxicity Profile [ Time Frame: Patients will continue the study treatment until disease progression, unacceptable toxicity, or development of any of the criteria for patient discontinuation ]

Dates:
Date Received: January 13, 2009
Date Started: August 2007
Date Completion: September 2016
Last Updated: March 15, 2016
Last Verified: March 2016