Gemcitabine, Oxaliplatin, Tarceva &/or Cisplatin in HCC & Biliary Tree Cancers (Gem-ox)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00832637
First received: January 13, 2009
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Cholangiocellular Carcinoma
Cholangiocarcinoma of the Extrahepatic Bile Duct
Bile Duct Cancer
Periampullary Adenocarcinoma
Gallbladder Cancer
Extrahepatic Bile Duct Cancer
Drug: Oxaliplatin
Drug: Erlotinib
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 82
Study Start Date: August 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Oxaliplatin
    Oxaliplatin is presented as a whitish freeze-dried powder packaged in glass vials. It is reconstituted by adding water for injection or 5% glucose solution and then diluting in an infusion solution. 100 mg/m2 on Day 2, 16 every 28 days
    Other Name: Eloxatin™
    Drug: Erlotinib
    150 mg orally daily.
    Other Name: Tarceva®
    Drug: Gemcitabine
    1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.
    Other Name: Gemzar®
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832637

Locations
United States, California
California Pacific Medical Center
San Francisco, California, United States, 94115
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Yehuda Patt, MD University of New Mexico
Principal Investigator: Ari D Baron, MD California Pacific Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00832637     History of Changes
Other Study ID Numbers: INST OX-05-024, NCI-2011-02729, B9E-US-X467
Study First Received: January 13, 2009
Last Updated: March 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:
Liver
Gallbladder
Bile duct
Gemzar
Eloxatin
Tarceva
erlotinib
Gem-ox

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Gallbladder Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Bile Duct Diseases
Liver Neoplasms
Liver Diseases
Gemcitabine
Oxaliplatin
Cisplatin
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014