Status:
WITHDRAWN
Combination Chemotherapy With or Without Ganitumab in Treating Patients With Previously Untreated Metastatic Pancreatic Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing ...
Detailed Description
OBJECTIVES: Primary * To assess the safety and determine the maximally tolerated dose (MTD) of modified FOLFIRINOX (mFOLFIRINOX) and ganitumab in patients with previously untreated, metastatic pancr...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma
- Metastatic disease to distant sites, as documented by CT scan or MRI
- Patients with locally advanced disease are NOT eligible
- At least one site of disease measurable by RECIST 1.1 criteria; defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 2 cm with conventional techniques or as ≥ 1 cm with spiral CT scan
- No known CNS metastases or carcinomatous meningitis, as determined by physical examination and/or imaging studies
- No suspected Gilbert syndrome or known homozygosity for the UGT1A1\*28 allele (UGT1A1 genotyping is not required for enrollment on this study; however, patients known to be homozygous for the UGT1A1\*28 allele are excluded)
- PATIENT CHARACTERISTICS:
- ECOG performance status 0 or 1
- Neutrophils ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN
- INR ≤ 1.5
- Blood glucose level ≤ 160 mg/dL
- Patients with non-fasting blood glucose \> 160 mg/dL must have a fasting blood glucose ≤ 160 mg/dL to be eligible
- Patients with diabetes mellitus are allowed at the discretion of the treating investigator, if blood sugars are felt to be under appropriate control
- Not pregnant or nursing
- Negative serum or urine pregnancy test
- No malignancy (other than non-melanoma skin cancer or carcinoma in situ of the cervix) diagnosed within the past 3 years or any currently active malignancy
- A malignancy is considered not "active" if all anti-cancer therapies were completed \> 3 years before enrollment and there is no current evidence of persistent disease
- No neurosensory or neuromotor toxicity ≥ grade 2
- No known allergy to platinum compounds or E. coli-derived products (e.g., filgrastim, humulin, insulin, or L-asparaginase)
- No colonic or small bowel disorders with uncontrolled symptoms at baseline (for example, \> 3 watery or soft stools daily in patients without colostomy or ileostomy)
- Patients with colostomy or ileostomy can be enrolled at the discretion of the investigator
- No history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within 6 months of registration
- No HIV-positive patients with a prior history of AIDS-defining illness
- No HIV-positive patients with a CD4 count of \< 450 cells/mm³ at any point prior to study
- Anti-retroviral therapy must be discontinued during study treatment
- No known positivity for chronic infection with B virus (HBV)
- PRIOR CONCURRENT THERAPY:
- Prior treatment with chemotherapy or radiotherapy for resected, locally advanced or metastatic pancreatic cancer is NOT allowed
- No prior treatment with inhibitors of the insulin-like growth factor 1 receptor
- No prior treatment with radiotherapy to greater than 25% of bone marrow
- Palliative radiation therapy may NOT be administered while a subject is on the study
- No major surgery within 4 weeks of the start of study treatment
- Patients must have recovered from the side effects of any major surgery at the start of study treatment
- Major surgery is defined as those surgeries that require general anesthesia
- Insertion of a vascular access device or endobiliary stent is NOT considered major surgery
- No percutaneous biliary drain (endobiliary stents are allowed)
- Warfarin for INR goal \> 1.5 is prohibited
- Patients on warfarin with INR goal of ≤ 1.5 are eligible
- Hormones or other chemotherapeutic agents may NOT be administered except for steroids given for adrenal failure; hormones administered for non-disease-related conditions (e.g., insulin for diabetes); and intermittent use of dexamethasone as an antiemetic or for the prevention or treatment of ganitumab infusion reactions
- Patients receiving anti-retroviral therapy must discontinue such therapy while receiving study treatment
Exclusion
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01473303
Start Date
August 1 2012
Last Update
June 28 2016
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