First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma.

NCT01964287 | Completed Phase 1

• 1 other identifier: VA2012/25
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Based on conventional chemotherapy approach, data have indicated that the Folfirinox regimen is more effective and tolerate than the treatment by Gemcitabine alone in patients with metastatic pancreatic adenocarcinoma. A recent study combining gemcitabine and nab paclitaxel improve the objective response rate. Primary objective of this study is to identify the maximun tolerated dose and the recommended phase II dose of first line treatment combining gemcitabine plus nab-paclitaxel followed by folfirinox in metastatic pancreatic adenocarcinoma.

Conditions

Metastatic Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Determination of the MTD

  Phase I: Identify the maximum tolerated dose and the recommended phase II dose of first line treatment combining gemcitabine plus nab-paclitaxel followed by folfirinox in metatstatic pancreatic adenocarcinoma. Phase II: Objective response rate of patients treated with this new combination

  18 months

Secondary Outcomes (1)

• Overall survival

  12 months

Study Arms (1)

Gembrax followed by Folfirinox

EXPERIMENTAL

Gembrax: Albumin-bound paclitaxel followed by Gemcitabine Day 1,8,15 followed by 2 weeks of rest Folfirinox: Oxaliplatin, irinotecan, leucovorin, 5FU bolus and continuous

Drug: GEMBRAX; Drug: FOLFIRINOX

Interventions

GEMBRAX DRUG

Also known as: Albumin bound paclitaxel 125 mg/m², Gemcitabine 1000 mg/m²

Gembrax followed by Folfirinox

FOLFIRINOX DRUG

Also known as: Oxaliplatin 85 mg/m², Irinotecan 180 mg/m², Leucovorin 200 mg/m², 5FU bolus 400mg/m², 5FU continuous 2400 mg/m²

Gembrax followed by Folfirinox

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the radiologic data.
• One or more metastatic tumors measurable metastatic lesions by CT scan of the abdomen, pelvis and chest, or hepatic MRI and CT scan (abdomen, pelvis and chest) without injection, if patient is allergic to CT contrast media).
• No previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
• Prior treatment with 5 FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided that at least 6 months have relapsed since completion of the last dose and no lingering toxicities are present.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
• Males or females aged 18 to 75 years at the time of signing the Informed Consent Form (ICF).
• Adequate blood function at baseline (obtained within 14 days before start of study treatment)
• Adequate liver and renal function at baseline (obtained within 14 days before start of study treatment)
• Patient has no clinical significant abnormalities in urinalysis results (obtained ≤ 14 days before start of study treatment)
• Patient has acceptable coagulation values (obtained ≤14 days prior to the first administration of study drug)
• Patient should be asymptomatic for jaundice prior to the first administration of study drug (Day1). Significant or symptomatic amounts of ascites should be drained prior to Day 1.
• Pain symptoms should be stable and should not require modifications in analgesic management prior to Day 1 of treatment.
• Life expectancy ≥ 2 months
• Non-pregnant and non-lactating female. If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (β-hCG) documented 72 hours prior to randomization.
• If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator during the period of administration of study drug. In addition, male and female patients must utilize contraception after the end of treatment as recommended in the product's Summary of Product Characteristics or Prescribing Information provided in the study manual.

You may not qualify if:

• Known brain metastases.
• Patient has only locally advanced disease.
• History of other malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
• Patients having received cytotoxic doses of any other chemotherapy (than 5FU and gemcitabine) in the adjuvant setting.
• Peripheral sensory neuropathy ≥ grade 2 at the time of signing the ICF.
• Active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
• Known historical or active infection with HIV.
• Major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
• History of allergy or hypersensitivity to any of the study drugs or any of their excipients, or the patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the SmPCs or Prescribing Information.
• History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa).
• Patients with high cardiovascular risk, including, but not limited to, coronary stenting or myocardial infarction in the past year.
• History of Peripheral Artery Disease (e.g. claudication, Leo Buerger's disease).
• Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
• Enrollment in any other clinical protocol within 4 weeks of signing the ICF.
• Patient is unwilling or unable to comply with study procedures, or is planning to take vacation for 7 or more consecutive days during the course of the study.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Institut regional du Cancer - Val d Aurelle

Montpellier, 34298, France

Location

MeSH Terms

Interventions

Albumin-Bound Paclitaxel; Gemcitabine; folfirinox; Oxaliplatin; Irinotecan; Leucovorin

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Design

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

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: October 17, 2013
• Study Start: September 24, 2013
• Primary Completion: December 22, 2016
• Study Completion: December 30, 2020
• Last Updated: December 31, 2020

Record last verified: 2020-12

Locations

FR (1)