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

Metastatic Pancreatic Adenocarcinoma Clinical Trial

— SEQUENCE  

Official title:

A Phase I/II Study of Nab-paclitaxel (Abraxane) and Gemcitabine Followed by Modified FOLFOX (AG-mFOLFOX) in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504333
• Other study ID #: TTD-14-05
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 2015
• Est. completion date: April 2021

Study information

• Verified date: September 2023
• Source: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically and/or cytologically confirmed pancreatic adenocarcinoma

2. Stage IV disease (metastatic only)

3. No prior systemic therapy for their diagnosis (except in adjuvant/neoadjuvant setting>six months previously)

4. ECOG performance status of 0-1

5. At least 18 years of age

6. 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)

7. 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.

8. Adequate bone marrow function:

• ANC = 1500/uL
• platelet count = 100,000/uL
• hemoglobin = 9.0 g/dL

9. Adequate hepatic function:

• Total bilirubin = 1.5 X ULN
• AST (SGOT) = 2.5 X ULN
• ALT (SGPT) = 2.5 X ULN

10. 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).

11. Ability to understand the nature of this study protocol and give written informed consent.

12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

1. 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.

2. Presence of central nervous system or brain metastases.

3. Life expectancy < 12 weeks

4. Pregnancy (positive pregnancy test) or lactation.

5. Pre-existing sensory neuropathy > grade 1.

6. 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.

7. Major surgery and/or radiotherapy within 4 weeks of the start of study treatment, without complete recovery.

8. 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Pancreatic Adenocarcinoma

Intervention

Drug:
• nab-paclitaxel
Day 1-8-15: Intravenous, 125 mg/m2 over 30 minutes
• gemcitabine
Day 1-8-15: Intravenous, 1.000 mg/m2 over 30 minutes
• m-FOLFOX
Day 28 according to the dose levels stablished in Phase I
• nab-paclitaxel
Day 1-8-15: Intravenous 30 minutes according to the dose levels stablished in Phase I
• gemcitabine
Day 1-8-15: Intravenous 30 minutes according to the dose levels stablished in Phase I

Locations

Country	Name	City	State
Spain	Spanish Cooperative for Digestive Tumour Therapy (TTD)	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	microRNA expression levels and their correlation with tumour-efficacy parameters		54 months
Other	Biomarker determination (tissue sample at basal point and blood samples at basal and at the end of treatment). Correlation with treatment response		54 months
Primary	Dose-limiting toxicity for the AG-mFOLFOX combination	Primary outcome phase I.	12 weeks
Primary	Rate of overall survival al 12 months	Primary outcome phase II	12 weeks
Secondary	Rate of overall survival at 6 months		54 months
Secondary	Rate of overall survival at 24 months		54 months
Secondary	Time to tumor progression		54 months
Secondary	Progression free survival		54 months
Secondary	Overall Survival		54 months
Secondary	Objective radiographic response	Secondary outcome Phase I and Phase II	54 months
Secondary	CA 19-9 biomarker response		54 months
Secondary	Safety profile of this combination (AG-mFOLFOX) using NCI-CTCAE v.4 criteria	Secondary outcome Phase I and Phase II	54 months
Secondary	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

External Links

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