a study of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan in metastatic pancreatic cancer

Conditions: Adenocarcinoma; Pancreatic Neoplasms; Neoplasm, Glandular; Neoplasms; Neoplasms Pancreatic; Digestive System Neoplasm; Endocrine Gland Neoplasms; Digestive System Disease; Pancreatic Diseases; Endocrine System Diseases

Summary: the purpose of this study is to evaluate the clinical activity of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (gax-ci) in patients with metastatic pancreatic cancer.

this was a two-part, single-institution, open-label, dose-escalation, phase 1/2 study to evaluate the clinical activity of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan in patients with metastatic pancreatic cancer. part 1 of the study was a phase 1 3 + 3 dose escalation study designed to evaluate the maximally tolerated dose (mtd) and safety of increasing doses of nab-paclitaxel in combination with gemcitabine, capecitabine, cisplatin, and irinotecan. there were two cohorts of dose escalations. the two cohorts differed based on the treatment cycle length (28 days for cohort 1 and 21 days for cohort 2). dose escalation started with cohort 1. enrollment for cohort 2 dose level 1 began once dose level 2 of cohort 1 was shown to be safe and did not exceed mtd. part 2 was a phase 2 expansion cohort study for the evaluation of efficacy once the mtd had been determined.

Eligibility criteria:
inclusion criteria: * have histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma. * patients with the presence of at least one measurable lesion. * male or non-pregnant and non-lactating female of age \>18 years. * eastern cooperative oncology group (ecog) performance status 0 or 1. * patients must have adequate organ and marrow function defined by study-specified laboratory tests. * must use acceptable form of birth control while on study. * ability to understand and willingness to sign a written informed consent document. exclusion criteria: * patients who will be considered for surgery are ineligible. * patient who have had any prior chemotherapy within 5 years of enrollment. * patient who have had radiotherapy for pancreatic cancer. * age ≥ 76 years * patient who is receiving or have received any other investigational agents within 28 days prior to day 1 of treatment in this study. * patient who has undergone major surgery, other than diagnostic surgery within 28 days prior to day 1 of treatment in this study. * patient who has known brain metastases. * patient with history of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, capecitabine, cisplatin, or irinotecan. * patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * patient who has serious medical risk factors involving any of the major organ systems. * patient who has known history of infection with hiv, hepatitis b, or hepatitis c. * pregnant or breast feeding. * patient is unwilling or unable to comply with study procedures * patient with clinically significant wound.