Phase I/II Study to Evaluate Nab-paclitaxel in Substitution of CPT11 or Oxaliplatin in FOLFIRINOX Schedule as First Line Treatment in Metastatic Pancreatic Cancer

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

At this moment, FOLFIRINOX is the best treatment for selected patients (pts) with metastatic pancreatic cancer (mPC). Investigator would like to evaluate the substitution of CPT11 or Oxaliplatin in FOLFIRINOX schedule with Nab-paclitaxel (Nab-p) [Nab-FOLFIRI and Nab-FOLFOX].

Doses for Nab-FOLFIRI and Nab-FOLFOX will be determined by the phase I trial. One or both schedules will be evaluated in successive phase II part.

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

Details

• Lead Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica
• Treatments: Albumin-Bound Paclitaxel; Oxaliplatin; Paclitaxel

Criteria

Inclusion Criteria:

• . Males or females ≥ 18 years old and ≤ 75 years old;

• Histological or cytological evidence of a diagnosis of pancreatic ductal adenocarcinoma;

• Written informed consent prior to any study-specific procedures; 4. Measurable metastatic disease, defined in according to RECIST Version 1.1 (Eisenhower et al. 2009), that had not previously been treated with CT for metastatic disease;

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1 ;

• Absence of previous abdominal radiotherapy on target lesions (except radiation therapy analgesic if it has not been performed on measurable targets);

• Absence of heart failure or angina or infarction within 12 months previous inclusion;

• Have adequate organ function including:

Hematologic: absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L.

Hepatic: Bilirubin ≤ 1.5 times upper limits of normal (ULN) (Pts may have endoscopic or radiologic stenting to treat biliary obstructions).

Renal: Serum creatinine within normal limits ≤1.5 times ULN.

Exclusion Criteria:

• Age of 76 years or older;

• Endocrine or acinar pancreatic carcinoma;

• Previous radiotherapy for measurable lesions;

• Central nervous system metastasis;

• Other concomitant cancer or history of cancer outside a carcinoma in situ of the cervix or basal or squamous cell of the skin;

• Pts already included in another clinical trial with other experimental drugs;

• Current active infection;

• Have serious pre-existing medical conditions or serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator (for example, unstable angina pectoris, or a clinically significant history of cardiac disease or uncontrolled diabetes mellitus);

• Females who are pregnant or lactating;

• Unable to undergo medical test for geographical, social or psychological reason

• Known dihydropyrimidine dehydrogenase (DPD) deficiency