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Gemcitabine, Oxaliplatin, Tarceva &/or Cisplatin in HCC & Biliary Tree Cancers | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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)

NCT00832637•New Mexico Cancer Research Alliance

View on ClinicalTrials.gov

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 Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed hepatocellular carcinoma (HCC) or biliary tree cancer (BTC:: intra- and extra-hepatic cholanciocarcinoma, bile duct cancer, adenocarcinoma of the Ampulla of Vater and/or gallbladder carcinoma).
•Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST).
•Age 18 years or older.
•Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2
•Adequate bone marrow as evidenced by:
•* Absolute neutrophil count (ANC) \> 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:
+6 more criteria

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 degrees Celcius within 3 days of the first scheduled day of protocol treatment.
•Patients with active central nervous system (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 prostate serum antigen (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.
+13 more criteria

Locations (2)

California Pacific Medical Center

San Francisco, California, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Key Dates

Start Date

August 1, 2007

Primary Completion Date

June 1, 2013

Completion Date

March 15, 2017

Last Updated

June 29, 2018

Enrollment

ACTUAL participants

Conditions

Hepatocellular CarcinomaCholangiocellular CarcinomaCholangiocarcinoma of the Extrahepatic Bile DuctBile Duct CancerPeriampullary AdenocarcinomaGallbladder CancerExtrahepatic Bile Duct Cancer

Interventions

Cisplatin

DRUG

Erlotinib

DRUG

Gemcitabine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Early Detection of Liver Cancer by QUS

Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer

A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)