Status:
COMPLETED
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
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Stage IV Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
PRIMARY OBJECTIVES: I. To assess the appropriate dose of IMC-A12 (cixutumumab) to use in combination with gemcitabine (gemcitabine hydrochloride) and erlotinib (erlotinib hydrochloride). (Phase I) II...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2014
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00617708
Start Date
March 1 2008
End Date
February 25 2014
Last Update
February 8 2022
Active Locations (146)
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1
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, United States, 72401
2
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States, 94704
3
Mills - Peninsula Hospitals
Burlingame, California, United States, 94010
4
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546