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

NCT00832637 | Terminated Phase 2 Results DMC

• 3 other identifiers: INST OX-05-024NCI-2011-02729B9E-US-X467
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatocellular Carcinoma; Cholangiocellular Carcinoma; Cholangiocarcinoma of the Extrahepatic Bile Duct; Bile Duct Cancer; Periampullary Adenocarcinoma; Gallbladder Cancer; Extrahepatic Bile Duct Cancer

Keywords

Liver; Gallbladder; Bile duct; Gemzar; Eloxatin; Tarceva; erlotinib; Gem-ox

Outcome Measures

Primary Outcomes (1)

• Tumor Control Rate

  Rate of tumor control is defined as the percentage of patients achieving a complete response (CR) + partial response (PR) + stable disease (SD) 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.

  24 weeks

Secondary Outcomes (4)

• Overall Response Rate

  24 weeks

• Time to Tumor Progression (TTP)

  2 years

• Median Survival Time (MST)

  2 years

• Toxicity

  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

Study Arms (1)

Gemcitabine, Cisplatin, Erlotinib

EXPERIMENTAL

A combination of Cisplatin at 40 mg/m2 + Gemcitabine at 1000 mg/m2, every 28 days + Erlotinib 100 mg daily, orally. Cycles will be repeated every four weeks.

Drug: Cisplatin; Drug: Erlotinib; Drug: Gemcitabine

Interventions

Cisplatin DRUG

Cisplatin is administered intravenously at 40 mg/m2 on day 1 and day 15, every 28 days. Cisplatin is administered following Gemcitabine. Cisplatin administration should occur with hydration with normal saline at 250 mL/ hour for at least 4 hours before and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.

Also known as: Platinol®

Gemcitabine, Cisplatin, Erlotinib

Erlotinib DRUG

100 mg orally daily. For grade 3 or 4 skin rash, erlotinib should be held until resolution of the rash to no more than grade 1 before resumption of erlotinib.

Also known as: Tarceva®

Gemcitabine, Cisplatin, Erlotinib

Gemcitabine DRUG

Gemcitabine is administered intravenously at 1000 mg/m2 on day 1 and 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 hydrochloride (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.

Also known as: Gemzar®

Gemcitabine, Cisplatin, Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Serum total bilirubin 1.5x Upper Limit of Normal (ULN).
• Alkaline phosphatase \< 3x ULN for the reference lab (\< 5x ULN for patients with known hepatic metastases).
• Serum glutamic-oxaloacetic transaminase (SGOT)/ serum glutamic-pyruvic transaminase (SGPT) \< 3x ULN for the reference lab (\< 5x ULN 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.

You may not qualify if:

• 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.
• 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 \> 1.5x ULN.

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (2)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

Related Links

• University of New Mexico Cancer Center
• New Mexico Cancer Care Alliance

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Cholangiocarcinoma; Bile Duct Neoplasms; Gallbladder Neoplasms

Interventions

Cisplatin; Erlotinib Hydrochloride; Gemcitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Yehuda Patt, MD
• Organization: University of New Mexico

yzpatt@salud.unm.edu

5059250405

Study Officials

• Yehuda Patt, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Ari D Baron, MD

  California Pacific Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 30, 2009
• Study Start: August 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: March 15, 2017
• Last Updated: June 29, 2018
• Results First Posted: July 14, 2015

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)