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A Randomized Placebo Controlled Study Of OSI-774 (TARCEVA) Plus Gemcitabine In Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer

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Trial Conditions
  • Pancreatic Cancer
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed adenocarcinoma of the pancreas

- Locally advanced or metastatic disease that is considered unresectable

- No known CNS metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin less than 2 times upper limit of normal (ULN)

- AST and/or ALT less than 2 times ULN (5 times ULN if liver metastases present)

Renal:

- Creatinine less than 1.5 times ULN

Cardiovascular:

- No uncontrolled high blood pressure

- No unstable angina

- No congestive heart failure

- No myocardial infarction within the past year

- No cardiac ventricular arrhythmias requiring medication

Gastrointestinal:

- No gastrointestinal (GI) tract disease resulting in an inability to take oral
medication such as uncontrolled inflammatory GI disease (e.g., Crohn's disease or
ulcerative colitis)

- No post-surgical malabsorption characterized by:

- Uncontrolled diarrhea that results in weight loss and vitamin deficiency OR

- Requires IV hyperalimentation

- Pancreatic enzyme supplementation allowed provided that the above criteria are
not met

Ophthalmic:

- No ocular inflammation or infection unless fully treated prior to study

- No significant ophthalmologic abnormalities, including the following:

- Severe dry eye syndrome

- Sjogren's syndrome

- Keratoconjunctivitis sicca

- Severe exposure keratopathy

- Disorders that would increase the risk for epithelium-related complications
(e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic
keratitis)

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No serious active infection

- No other serious underlying medical, psychological, or geographical condition that
would preclude study participation

- No prior allergic reaction to compounds with similar chemical or biologic composition
to erlotinib

- No other prior malignancy within the past 5 years except cancer in situ or basal cell
or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent biologic therapy or immunotherapy

Chemotherapy:

- No prior chemotherapy except fluorouracil (with or without leucovorin calcium) or
gemcitabine administered concurrently with radiotherapy as a radiosensitizer

- No other concurrent cytotoxic chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Chemotherapy

- At least 4 weeks since prior radiotherapy and recovered

- Prior radiotherapy for local disease allowed if evidence of disease progression has
occurred

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- At least 2 weeks since prior major surgery

- No concurrent ophthalmic surgery

Other:

- No prior epidermal growth factor receptor inhibitors

- At least 2 weeks since prior investigational drug

- No other concurrent investigational drugs during and for at least 30 days after study

- No other concurrent anti-cancer therapy

Gender: Both
Steward Physician(s)
  • Malcolm J. Moore, MD
Trial Interventions
Drug
  • erlotinib hydrochloride
  • gemcitabine hydrochloride
Physician Researcher

Investigator Name:

  • Malcolm J. Moore, MD

Other Information

Sponsor: NCIC Clinical Trials Group
Phase: Phase 3
Trial ID: NCT00026338
Volunteers:  Not Accepting Healthy Volunteers

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