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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma, Cholangiocellular Carcinoma, Cholangiocarcinoma of the Extrahepatic Bile Duct, Bile Duct Cancer, Periampullary Adenocarcinoma, Gallbladder Cancer, Extrahepatic Bile Duct Cancer

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Trial Information

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)


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/┬ÁL. 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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

Patients will continue the study treatment until disease progression, unacceptable toxicity, or development of any of the criteria for patient discontinuation

Safety Issue:

Yes

Principal Investigator

Yehuda Patt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico

Authority:

United States: Institutional Review Board

Study ID:

INST OX-05-024

NCT ID:

NCT00832637

Start Date:

August 2007

Completion Date:

December 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • Cholangiocellular Carcinoma
  • Cholangiocarcinoma of the Extrahepatic Bile Duct
  • Bile Duct Cancer
  • Periampullary Adenocarcinoma
  • Gallbladder Cancer
  • Extrahepatic Bile Duct Cancer
  • Liver
  • Gallbladder
  • Bile duct
  • Gemzar
  • Eloxatin
  • Tarceva
  • erlotinib
  • Gem-ox
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Cholangiocarcinoma
  • Carcinoma, Hepatocellular

Name

Location

University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
California Pacific Medical Center San Francisco, California  94115