QUILT-3.010: A Study of Gemcitabine and Nab-paclitaxel With or Without NPC-1C to Treat Patients With Pancreatic Cancer
Pancreatic Cancer, Adult
About this trial
This is an interventional treatment trial for Pancreatic Cancer, Adult focused on measuring Pancreatic neoplasms, Pancreatic cancer, Pancreatic cancer, adult, Adenoma of the pancreas, Carcinoma of the pancreas
Eligibility Criteria
Inclusion Criteria
- Subjects with recurrent, locally advanced unresectable or metastatic adenocarcinoma of the pancreas who have progressed after primary therapy with FOLFIRINOX or FOLFIRINOX-like regimen or were intolerant of it.
- IHC greater than or equal to 20 percent of tumor on tissue sections must stain with NPC-1C.
- 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Have an anticipated life expectancy of greater than 8 weeks.
- Have recovered from any acute toxicity related to prior therapy.
- If female, is post-menopausal, surgically sterilized or willing to use an effective method of contraception for the duration of the study and for 3 months after the end of treatment. If male, has agreed to use barrier method for contraception for the duration of the study and for 3 months after the end of treatment.
- Must be willing to sign a written informed consent.
Laboratory tests must meet minimum safety requirements
- Hemoglobin greater than or equal to 8.5 g/dL (may be receiving supportive therapy)
- ANC greater than or equal to 1,500 K/uL
- Platelets greater than or equal to 100 K/uL
- Total bilirubin less than or equal to 2 mg/dL
- ALT/AST less than or equal to 3 times ULN or less than or equal to 5 times ULN in the setting of liver metastases.
- Creatinine less than or equal to 1.5 mg/dL or creatinine clearance greater than 40 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, as calculated by the Cockcroft Gault formula.
- Men and women of all races and ethnic groups are eligible for this trial.
Exclusion Criteria
- Have received a second line chemotherapy after progressing on or not tolerating treatment with FOLFIRINOX as a first line. Prior adjuvant/neoadjuvant gemcitabine or gemcitabine-based radiation will not be counted as first line therapy.
- Have known brain metastases.
- Have had any major surgery within four weeks of enrollment.
- Have greater than grade 2 ascites at time of enrollment.
- Have received Gemcitabine for palliative treatment or progressed while receiving it or is within 3 months of completion in the adjuvant setting.
- Have uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Have serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Must not have other invasive malignancies within the past 3 years (with the exception of non-melanoma skin cancers or non-invasive bladder cancer).
- Is pregnant or breast-feeding, since the effects of NPC-1C on the developing human fetus and nursing infants are unknown and potentially harmful, women of child-bearing potential must agree to use adequate contraception (hormonal or double barrier method of birth control or complete abstinence) prior to study entry, for the duration of study participation, and for three months after the last dose of investigational agent.
- Have had any chemotherapy or systemic corticosteroids within 2 weeks of study entry.
- Have acquired, hereditary or congenital immunodeficiencies including cellular immunodeficiencies, hypogammaglobulinemia and dysgammaglobulinemia.
- Have a prior history of a documented hemolytic event.
- Have a history of hypersensitivity to human or mouse antibody products.
- Have a known history of HIV are excluded due to the possibility that Gemcitabine or NPC-1C(NEO-102) may worsen their condition and the likelihood that the underlying condition may obscure the attribution of adverse events with respect to Gemcitabine or NPC-1C(NEO-102).
Sites / Locations
- California Pacific Medical Center
- Smilow Cancer Hospital- Yale
- University of Miami
- National Cancer Institute
- Massachusetts General Hospital
- Beht Isreal Deaconess Medical Center
- Dana Farber Cancer Institute
- Washington University in St. Louis
- University of North Carolina at Chapel Hill
- Duke University
- Thomas Jefferson University Hospital
- UT Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Abraxane, gemcitabine
Abraxane, gemcitabine, NPC-1C
Nab-paclitaxel will be administered at a dose of 125 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) followed by 1000 mg/m2 gemcitabine as a 30 minute infusion for 3 consecutive weeks followed by a week of rest.
Nab-paclitaxel will be administered at a dose of 125 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) followed by 1000 mg/m2 gemcitabine as a 30 minute infusion for 3 consecutive weeks followed by a week of rest. Patients on arm B will receive NPC-1C(NEO-102) infusion at a dose of 1.5mg/kg IV on days 1 and 15 of a 4-week cycle. This will be administered 30minutes after completion of the gemcitabine infusion.