S0727 Gemcitabine Hydrochloride and Erlotinib Hydrochloride With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase I/II trial is studying the side effects and best dose of monoclonal antibody therapy when given together with gemcitabine hydrochloride and erlotinib hydrochloride and to see how well they work compared with giving gemcitabine hydrochloride and erlotinib hydrochloride alone as first-line therapy in treating patients with metastatic pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving erlotinib hydrochloride and gemcitabine hydrochloride together with monoclonal antibody therapy may kill more tumor cells.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Erlotinib Hydrochloride; Gemcitabine

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed pancreatic adenocarcinoma

• Stage IV disease (any T, any N, M1 [distant metastases])

• Unresectable disease

• Histologic diagnosis based on a metastatic site must be compatible with pancreatic cancer

• Measurable and/or nonmeasurable disease

• No endocrine or neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer

• No macroscopic residual disease post-resection as the only site of disease

• No clinically significant ascites

• No known brain metastases

• Patients with neurologic signs or symptoms must undergo brain imaging studies AND studies must be negative for disease

• Zubrod performance status 0-1

• ANC ≥ 1,500/mcL

• Platelet count ≥ 100,000/mcL

• Hemoglobin ≥ 9 g/dL

• Leukocytes ≥ 3,000/mcL

• Total bilirubin normal

• SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)

• Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min

• Fasting serum glucose < 120 mg/dL or below the ULN

• Patients with diabetes mellitus who meet this criterion must be on a stable dietary or therapeutic regimen for this condition

• INR ≤ 1.5 and PTT ≤ 5 seconds above ULN

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Willing to submit previously collected tumor tissue specimens

• No history of allergic reaction attributed to compounds of similar chemical or biological composition to anti-IGF-1R recombinant monoclonal antibody IMC-A12

• No active acute or chronic infections requiring antibiotics

• No significant ongoing cardiac problems, including any of the following:

• Myocardial infarction within the past 6 months

• Uncontrolled hypertension

• Unstable angina

• Uncontrolled arrhythmia

• Congestive heart failure

• No known HIV infection

• No other prior malignancy, except for the following:

• Adequately treated basal cell or squamous cell skin cancer

• Carcinoma in situ of the cervix

• Adequately treated stage I or II cancer from which the patient is currently in complete remission

• Any other cancer from which the patient has been disease-free for 5 years

• At least 14 days since prior surgery

• At least 28 days since prior radiotherapy for palliation to metastatic sites

• Patient must have other untreated metastatic sites that would qualify them for this protocol

• At least 6 months since prior adjuvant chemotherapy

• No prior chemotherapy, hormonal therapy, immunotherapy, or chemoradiotherapy for advanced or locally advanced pancreatic cancer, including drugs that target either EGFR or IGFR

• No plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other type of therapy for treatment of cancer

• No prior gemcitabine hydrochloride

• No prior chimerized or murine monoclonal antibody therapy

• No concurrent CYP3A4 inducers including, but not limited to, any of the following:

• Rifampicin

• Rifabutin

• Rifapentine

• Phenytoin

• Carbamazepine

• Phenobarbital

• Hypericum perforatum (St. John's wort)

• No concurrent CYP3A4 inhibitors including, but not limited to, any of the following:

• Atazanavir

• Clarithromycin

• Indinavir

• Itraconazole

• Ketoconazole

• Nefazodone

• Nelfinavir

• Ritonavir

• Saquinavir

• Telithromycin

• Troleandomycin

• Voriconazole

• Concurrent prophylactic low-dose coumadin or low molecular weight heparin allowed provided coagulation criteria are met

• Full-dose anticoagulation allowed provided coagulation criteria are met and are under strict control and monitoring