Study of Abraxane® and gemcitabine followed by modified FOLFOX in patients with previously untreated, metastatic pancreatic adenocarcinoma

Phase 1

• Conditions: MedDRA version: 18.0Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 100000004864; Metastatic pancreatic cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-005350-19-ES
• Lead Sponsor: Grupo de Tratamiento de los Tumores Digestivos (TTD)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-08
• Study Completion: 2021-04-10
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

- Histologically and/or cytologically confirmed pancreatic adenocarcinoma
- Stage IV disease (metastatic pancreatic cancer).
- No prior systemic therapy for their diagnosis (except in adjuvant setting with or without radiotherapy during previous six months.
- ECOG performance status of 0-1
- At least 18 years of age
- RECIST versión 1.1. defined measurable disease
- 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 or until 2mg/dL
AST (SGOT) = 2.5 X ULN = 5 X ULN if liver metastases
ALT (SGPT) = 2.5 X ULN = 5 X ULN if liver metastases
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- 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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified