S0205 Gemcitabine w/ or w/o Cetuximab as First-Line Therapy in Locally Advanced Pancreas Cancer | NCT00075686 | Trialant

S0205 Gemcitabine w/ or w/o Cetuximab as First-Line Therapy in Locally Advanced Pancreas Cancer | NCT00075686 | Trialant

Official Title: 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
Brief Summary: 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.
Detailed Description: OBJECTIVES:

Compare the overall survival of patients with locally advanced unresectable or metastatic adenocarcinoma of the pancreas treated with gemcitabine and cetuximab vs gemcitabine alone.

Compare the time to treatment failure in patients treated with these regimens.

Estimate the percentage of patients with epidermal growth factor receptor (EGFR) tumor expression in patients treated with these regimens.

Compare the overall survival of patients in the EGFR-positive subset treated with these regimens.

Compare the toxicity of these regimens in these patients.

Compare the total response rate (confirmed and unconfirmed complete and partial response) in patients with measurable disease treated with these regimens.

Compare the patient report of pain and quality of life of patients treated with these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to disease status (locally advanced unresectable vs metastatic), Zubrod performance status (0 or 1 vs 2), and prior pancreatectomy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22 and gemcitabine IV over 30 minutes on days 1, 8, 15, and 22 for course 1 and days 1, 8, and 15 for all subsequent courses.

Arm II: Patients receive gemcitabine as in arm I. In both arms, courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each course, and at the end of study therapy.

Patients are followed every 6 months for 2 years and then annually for 1 year.

PROJECTED ACCRUAL: A total of 704 patients (352 per treatment arm) will be accrued for this study within 5 years.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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