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

NCT02109341 | Completed Phase 1 DMC

• 2 other identifiers: Goirc 01-20132013-002275-18
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Metastatic Pancreatic Cancer

Keywords

mPC

Outcome Measures

Primary Outcomes (1)

• Dose finding safety and activity

  To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of the combination Nab-paclitaxel+ Irinotecan+ Leucovorin+ 5-Fluorouracil (Nab-FOLFIRI) and of the combination Nab-paclitaxel+ Oxaliplatin+ Leucovorin+ 5-Fluorouracil (Nab- FOLFOX) in pts with mPC in first-line chemotherapy (CT). To assess efficacy of Nab-FOLFIRI and Nab-FOLFOX in pts with mPC in first-line CT , in term of ORR \[Complete response (CR) + partial responses (PR)\].

  18 months

Secondary Outcomes (5)

• Clinical benefit rate [CR+PR+ stable diseases (SD)]

  18 months

• Progression free survival (PFS) for each schedule

  18 months

• Overall survival (OS),

  18 months

• Quality of life (QoL) for each schedule

  18 months

• Safety profile

  18 months

Study Arms (2)

Nab-FOLFIRI

EXPERIMENTAL

In the phase I study, all pts enrolled in this arm will receive Nab-FOLFIRI: Irinotecan, 180 mg per square meter of body surface area (m2 ) + Leucovorin, 400 mg/m2 and 5-Fluorouracil, 400 mg/m2 given as a bolus followed by 2400 mg/m2 given as a 46-hour continuous infusion, plus Nab-p per cohort escalation assignment starting with 90 mg/m2 every 2 weeks. Pts continued treatment until a total of 12 administrations, disease progression or unacceptable toxicity. Pts enrolled in arm A for phase II will receive the dose of Nab-FOLFIRI as determined in the Phase I and in the same sequence.

Drug: Paclitaxel bound albumine

Nab-FOLFOX

EXPERIMENTAL

In the phase I study, all pts enrolled in this arm will receive Nab-FOLFOX: Oxaliplatin 85 mg/m2 +Leucovorin, 400 mg/m2 and 5-Fluorouracil, 400 mg/m2 given as a bolus followed by 2400 mg/m2 given as a 46-hour continuous infusion, plus Nab-p per cohort escalation assignment starting with 90 mg/m2, every 2 weeks. Pts continued treatment until a total of 12 administrations, disease progression or unacceptable toxicity. Pts enrolled in arm B for phase II will receive the dose of Nab-FOLFOX as determined in the Phase I and in the same sequence

Drug: Paclitaxel bound albumine

Interventions

Paclitaxel bound albumine DRUG

Also known as: nab-paclitaxel

Nab-FOLFIRI; Nab-FOLFOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gruppo Oncologico Italiano di Ricerca Clinica: lead

Study Sites (8)

Ospedale Sacro cuore di Gesù - FATEBENEFRATELLI

Benevento, BN, 82100, Italy

Location

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, FG, 71013, Italy

Location

SC Oncologia Medica 1

Florence, FI, 50134, Italy

Location

Regina Elena National Cancer Institute

Rome, Rome, 00144, Italy

Location

Azienda Ospedaliera Istituti Ospedalieri di Cremona

Cremona, 26100, Italy

Location

Ospedale S. Chiara - Azienda Ospedaliero-Universitaria Pisana

Pisa, 56126, Italy

Location

Arcispedale Santa Maria Nuova

Reggio Emilia, 42100, Italy

Location

Ospedale Borgo Roma

Verona, 37134, Italy

Location

Related Links

• Goirc Web site

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Francesco Di Costanzo, MD

  AOU- Careggi

  PRINCIPAL INVESTIGATOR

• Elisa Giommoni, MD

  Gruppo Oncologico Italiano di Ricerca Clinica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 9, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

IT (8)