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

Part of paid clinical trials in San Francisco, California.

Sponsor
New Mexico Cancer Research Alliance
Study ID
NCT00832637
Phase
PHASE2
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
Jan 30, 2009
Start date
Aug 31, 2007
Status verified
Jun 2018
Primary completion
Jun 30, 2013
Completion
Mar 15, 2017

Study Design

Enrollment
33 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitabine, Cisplatin, Erlotinib
    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.

Primary Outcome Measure

Tumor Control Rate [ Time Frame: 24 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
California Pacific Medical CenterSan FranciscoCalifornia94115-
University of New Mexico Cancer CenterAlbuquerqueNew Mexico87131-

Find similar trials in San Francisco, CA

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
California Pacific Medical Center· San Francisco, CAUniversity of New Mexico Cancer Center· Albuquerque, NM

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