Overview

This trial is active, not recruiting.

Conditions hepatocellular carcinoma, cholangiocellular carcinoma, cholangiocarcinoma of the extrahepatic bile duct, bile duct cancer, periampullary adenocarcinoma, gallbladder cancer, extrahepatic bile duct cancer
Treatments oxaliplatin, erlotinib, gemcitabine
Phase phase 2
Target EGFR
Sponsor New Mexico Cancer Care Alliance
Start date August 2007
End date June 2013
Trial size 82 participants
Trial identifier NCT00832637, B9E-US-X467, INST OX-05-024, NCI-2011-02729

Summary

The purpose of this study is to determine response rate of tumor control (CR+PR+SD at 24 weeks) following treatment with GEM-OX combined with Tarceva in patients with HCC.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically or cytologically confirmed HCC. - Patients must have measurable disease according to the RECIST criteria. - Age > 18 years. - ECOG Performance Score of 0-2 (Appendix A). - Adequate bone marrow as evidenced by: - Absolute neutrophil count > 1,500/L. - Platelet count > 100,000/L. - Absence of a regular red blood cell transfusion requirement. - Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL. - Adequate hepatic function as evidenced by: - Serum total bilirubin 1.5xULN. - Alkaline phosphatase < 3xULN for the reference lab (< 5xULN for patients with known hepatic metastases). - SGOT/SGPT < 3xULN for the reference lab (< 5xULN for patients with known hepatic metastases). - Patients must have a life expectancy of 12 weeks. - Patients must be recovered from both acute and late effects of any prior surgery, radiotherapy or other antineoplastic therapy. - Patients of childbearing potential agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method). Exclusion Criteria: A patient may not be enrolled in the trial if any of the following criteria are met: - Patients with an active infection or with a fever > 38.50 C within 3 days of the first scheduled day of protocol treatment. - Patients with active CNS metastases. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for 3 weeks are eligible for the trial. - History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations at least 3 months apart, with the most recent evaluation within 4 weeks of entry. - Patients with prior treatment or known hypersensitivity to any of the components of oxaliplatin or gemcitabine. - Patients who have received chemotherapy within 30 days of the first scheduled day of protocol treatment. - Patients who received radiotherapy to more than 25% of their bone marrow; or patients who received any radiotherapy within 4 weeks of entry. - Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication). - Peripheral neuropathy Grade 2. - Patients who are pregnant or lactating. - Patients with a life expectancy of less than 12 weeks. - Any other medical condition, including mental illness or substance abuse, deemed by the Investigator, likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results. - Patients with any of the following laboratory parameters: - Abnormal hematological values with ANC < 1500/mm3, thrombocytopenia < 99,000. - Impaired renal function with a serum creatinine > 1.5 ULN. - Serum bilirubin > 1.5xULN. - Albumin < 2.5mg/dl. - Unwillingness to participate or inability to comply with the protocol for the duration of the study. - History of allogeneic transplant. - Known HIV. - Clinically significant heart disease defined as NYHA class 3 or 4 heart disease. - Known or existing uncontrolled coagulopathy. - Patients with severe medical problems such as uncontrolled diabetes or chronically debilitating diseases that the investigator feels might compromise the study participant.

Additional Information

Official title Gemcitabine and Cisplatin With Erlotinib in Hepatocellular Carcinoma (HCC) and Biliary Tree Cancer (BTC) (Intra- and Extra-hepatic Cholangiocarcinoma, Bile Duct Cancer, Adenocarcinoma of the Ampulla of Vater and Gallbladder Carcinoma)
Principal investigator Yehuda Patt, MD
Description This is a single arm phase II trial of Gemcitabine and Oxaliplatin (Gem-Ox) with Erlotinib (Tarceva) for the treatment of hepatocellular carcinoma (HCC) patients with platelet counts 100,000/µL. All patients will be evaluated in consultation by medical oncology. Patients who are deemed candidates for this investigational protocol, will be given a consent document, and once patients understand the treatment plan, the risk, and the benefits involved in participation in the study they will sign the document. Consent will be obtained prior to initiation of the required study investigations, unless these are standard of care.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by New Mexico Cancer Care Alliance.