Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer

Conditions

• Pancreatic Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• erlotinib hydrochloride — DRUG
  150 mg po daily
• gemcitabine hydrochloride — DRUG
  1000 mg/m2 IV weekly (Cycle 1 -Day 1, 8, 15, 22, 29, 36, 43 of an 8 week cycle, Cycle 2 and subsequent cycles -Day 1,8 and 15 of a 4 week cycle)

Study Details

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as erlotinib use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and biological therapy may kill more tumor cells. It is not yet known if gemcitabine is more effective with or without erlotinib in treating pancreatic cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with and without erlotinib in treating patients who have unresectable locally advanced or metastatic pancreatic cancer.

Key Dates

First listed

Jan 27, 2003

Start date

Oct 29, 2001

Status verified

Mar 2020

Primary completion

Sep 17, 2004

Completion

Feb 10, 2009

Study Design

Enrollment

569 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: OSI-774 plus Gemcitabine
• Active Comparator: Placebo plus gemcitabine

Primary Outcome Measure

Overall survival [ Time Frame: 3 years ]

Locations (74)

Find similar trials in Tucson, AZ

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