Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AG | Active Comparator | nab-Paclitaxel followed by Gemcitabine |
|
| AG-mFOLFOX | Experimental | nab-Paclitaxel followed by Gemcitabine and FOLFOXm at dose levels selected from the phase I trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nab-paclitaxel | Drug | Day 1-8-15: Intravenous, 125 mg/m2 over 30 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of overall survival at 6 months | 54 months | |
| Rate of overall survival at 24 months | 54 months | |
| Time to tumor progression |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
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:
Adequate hepatic function:
Adequate renal function as determined by either:
- Calculated or measured creatinine clearance ≥ 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used).
Ability to understand the nature of this study protocol and give written informed consent.
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alfredo Carrato, MD PhD | Hospital Universitario Ramón y Cajal | Study Chair |
| Carmen Guillén, MD | Hospital Universitario Ramón y Cajal | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spanish Cooperative for Digestive Tumour Therapy (TTD) | Madrid | 28046 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38320486 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| gemcitabine |
| Drug |
Day 1-8-15: Intravenous, 1.000 mg/m2 over 30 minutes |
|
| m-FOLFOX | Drug | Day 28 according to the dose levels stablished in Phase I |
|
| nab-paclitaxel | Drug | Day 1-8-15: Intravenous 30 minutes according to the dose levels stablished in Phase I |
|
| gemcitabine | Drug | Day 1-8-15: Intravenous 30 minutes according to the dose levels stablished in Phase I |
|
| 54 months |
| Progression free survival | 54 months |
| Overall Survival | 54 months |
| Objective radiographic response | Secondary outcome Phase I and Phase II | 54 months |
| CA 19-9 biomarker response | 54 months |
| Safety profile of this combination (AG-mFOLFOX) using NCI-CTCAE v.4 criteria | Secondary outcome Phase I and Phase II | 54 months |
| To assess the Quality of Life of the patients through the EORTC QLQ-C30/PAN26 and EORTC QLQ-CIPN20 questionnaires | Secondary outcome Phase I and Phase II | 54 months |
| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided