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A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine As First-Line Therapy Of Patients With Advanced Pancreas Cancer

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

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether gemcitabine is more effective with or without cetuximab in treating pancreatic cancer. PURPOSE: This randomized phase III trial is studying giving gemcitabine together with cetuximab to see how well it works compared to giving gemcitabine alone as first-line therapy in treating patients with locally advanced unresectable or metastatic adenocarcinoma of the pancreas.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- Histologically* or cytologically confirmed pancreatic adenocarcinoma meeting 1 of the
following criteria:

- Locally advanced unresectable disease

- Distant metastatic disease NOTE: If diagnosis is based on a metastatic site the
histology must be compatible with pancreatic cancer

- Measurable or nonmeasurable disease by x-ray, scan, or physical examination

- Tumor tissue must be submitted for evaluation of epidermal growth factor receptor
expression before study entry

- None of the following tumor types are allowed:

- Endocrine tumors

- Lymphoma of the pancreas

- Ampullary cancer

- No known brain metastases

PATIENT CHARACTERISTICS:

Age

- Not specified

Performance status

- Zubrod 0-2

Life expectancy

- At least 3 months

Hematopoietic

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

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

Hepatic

- Bilirubin no greater than 2.0 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 2.5 times ULN

Renal

- Creatinine no greater than 2.0 mg/dL

Cardiovascular

- No significant history of cardiac disease

- No uncontrolled hypertension

- No unstable angina

- No uncontrolled arrhythmia

- No congestive heart failure

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- HIV negative

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer that is currently in remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior immunotherapy for advanced pancreatic cancer

- No prior cetuximab or other therapy that targets the epidermal growth factor pathway

- No prior chimerized or murine monoclonal antibody therapy

- No other concurrent anticancer immunotherapy

Chemotherapy

- At least 6 months since prior adjuvant chemotherapy

- No prior chemotherapy or chemoradiotherapy for advanced pancreatic cancer

- No prior gemcitabine

- No other concurrent anticancer chemotherapy

Endocrine therapy

- No prior hormonal therapy for advanced pancreatic cancer

- No concurrent anticancer hormonal therapy

Radiotherapy

- See Chemotherapy

- At least 28 days since prior radiotherapy and recovered

- Prior palliative radiotherapy to metastatic sites allowed

- No concurrent anticancer radiotherapy, including whole brain radiotherapy for
progressive disease (i.e., CNS metastasis)

Surgery

- At least 14 days since prior pancreatic cancer surgery and recovered

Other

- No other concurrent anticancer therapy

Gender: Both
Steward Physician(s)
  • Philip A. Philip, MD, PhD, FRCP
  • Eileen O'Reilly, MD
  • Ralph PW Wong, MD, FRCPC
Facilities
  • Holy Family Hospital - Completed
  • Norwood Hospital - Completed
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Biological
  • cetuximab
Drug
  • gemcitabine hydrochloride
Physician Researcher

Investigator Name:

  • Philip A. Philip, MD, PhD, FRCP
  • Eileen O'Reilly, MD
  • Ralph PW Wong, MD, FRCPC

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 3
Trial ID: NCT00075686
Volunteers:  Not Accepting Healthy Volunteers

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