Phase I/II Study of Nab-paclitaxel and Gemcitabine Followed by AG-mFOLFOX in Patients With Metastatic Pancreatic Adenocarcinoma

NCT02504333 | Completed Phase 1

• 1 other identifier: TTD-14-05
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and efficacy of nab-paclitaxel (Abraxane) and gemcitabine followed by modified FOLFOX (AG-mFOLFOX) in patients with previously untreated, metastatic pancreatic adenocarcinoma

Conditions

Metastatic Pancreatic Adenocarcinoma

Keywords

metastatic pancreatic adenocarcinoma; Nab-paclitaxel; Gemcitabine; modified FOLFOX

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity for the AG-mFOLFOX combination

  Primary outcome phase I.

  12 weeks

• Rate of overall survival al 12 months

  Primary outcome phase II

  12 weeks

Secondary Outcomes (9)

• Rate of overall survival at 6 months

  54 months

• Rate of overall survival at 24 months

  54 months

• Time to tumor progression

  54 months

• Progression free survival

  54 months

• Overall Survival

  54 months

Other Outcomes (2)

• microRNA expression levels and their correlation with tumour-efficacy parameters

  54 months

• Biomarker determination (tissue sample at basal point and blood samples at basal and at the end of treatment). Correlation with treatment response

  54 months

Study Arms (2)

AG

ACTIVE COMPARATOR

nab-Paclitaxel followed by Gemcitabine

Drug: nab-paclitaxel; Drug: gemcitabine

AG-mFOLFOX

EXPERIMENTAL

nab-Paclitaxel followed by Gemcitabine and FOLFOXm at dose levels selected from the phase I trial

Drug: m-FOLFOX; Drug: nab-paclitaxel; Drug: gemcitabine

Interventions

nab-paclitaxel DRUG

Day 1-8-15: Intravenous, 125 mg/m2 over 30 minutes

AG

gemcitabine DRUG

Day 1-8-15: Intravenous, 1.000 mg/m2 over 30 minutes

AG

m-FOLFOX DRUG

Day 28 according to the dose levels stablished in Phase I

AG-mFOLFOX

Eligibility Criteria

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

You may qualify if:

• Histologically and/or cytologically confirmed pancreatic adenocarcinoma
• Stage IV disease (metastatic only)
• No prior systemic therapy for their diagnosis (except in adjuvant/neoadjuvant setting\>six months previously)
• ECOG performance status of 0-1
• At least 18 years of age
• Evidence of either or both of the following RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20mm using conventional techniques or ≥10 mm with spiral CT scan)
• Female patients must be either surgically sterile or postmenopausal, or if of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment and agree to use effective barrier contraception during the period of therapy. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the investigator.
• Adequate bone marrow function:
• ANC ≥ 1500/uL
• platelet count ≥ 100,000/uL
• hemoglobin ≥ 9.0 g/dL
• Adequate hepatic function:
• Total bilirubin ≤ 1.5 X ULN
• AST (SGOT) ≤ 2.5 X ULN
• ALT (SGPT) ≤ 2.5 X ULN

You may not qualify if:

• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
• Presence of central nervous system or brain metastases.
• Life expectancy \< 12 weeks
• Pregnancy (positive pregnancy test) or lactation.
• Pre-existing sensory neuropathy \> grade 1.
• Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
• Major surgery and/or radiotherapy within 4 weeks of the start of study treatment, without complete recovery.
• Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years.

Sponsors & Collaborators

• Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD): lead

Study Sites (1)

Spanish Cooperative for Digestive Tumour Therapy (TTD)

Madrid, 28046, Spain

Location

Related Publications (1)

• Carrato A, Pazo-Cid R, Macarulla T, Gallego J, Jimenez-Fonseca P, Rivera F, Cano MT, Rodriguez-Garrote M, Pericay C, Ales I, Layos L, Grana B, Iranzo V, Gallego I, Garcia-Carbonero R, de Mena IR, Guillen-Ponce C, Aranda E. Nab-Paclitaxel plus Gemcitabine and FOLFOX in Metastatic Pancreatic Cancer. NEJM Evid. 2024 Feb;3(2):EVIDoa2300144. doi: 10.1056/EVIDoa2300144. Epub 2024 Jan 23.

  PMID: 38320486 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel; Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Alfredo Carrato, MD PhD

  Hospital Universitario Ramón y Cajal

  STUDY CHAIR

• Carmen Guillén, MD

  Hospital Universitario Ramón y Cajal

  STUDY CHAIR

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: July 20, 2015
• First Posted: July 21, 2015
• Study Start: July 1, 2015
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: October 3, 2023

Record last verified: 2023-09

Locations

ES (1)