The Study of Metastatic Pancreatic Adenocarcinoma

NCT01415713 | Completed Phase 1 DMC

• 1 other identifier: T1211
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I part, Primary objective: the maximum tolerated dose of S-1 in the SLOG regimen Secondary objectives: the dose-limiting toxicity of the regimen Phase II part, Primary objective: Overall tumor response rate (by RECIST criteria) Secondary objectives: Disease control rate (Objective response rate (ORR) + stable disease ≧ 16 weeks), Time to tumor progression, Progression-free survival, Overall survival ,Safety profile, Biomarker study

Conditions

Metastatic Pancreatic Adenocarcinoma

Keywords

enroll the 80 patients in this trial

Outcome Measures

Primary Outcomes (1)

• to determine the following items in patients with metastatic pancreatic adenocarcinoma receiving SLOG

  Patients will be entered in cohorts of three. In any dose level of S-1, if none develops DLT as listed after the first two doses of SLOG chemotherapy, another cohort of 3 patients will be accrued to the next dose level. If at any time two or more patients develop DLT at the same dose level, the dose escalation will be terminated, and the prior dosage level will be considered the MTD.

  one year

Secondary Outcomes (1)

• to evaluate the following items in patients with metastatic pancreatic adenocarcinoma receiving SLOG treatment,

  one year

Study Arms (1)

Statin dose titration

EXPERIMENTAL

SLOG regimen: S-1 20-40 mg/m2/b.i.d., day 1-7;Leucovorin 20 mg/m2/b.i.d., day 1-7;Oxaliplatin 85 mg/m2 in 250 mL of D5W,given as 2-hour intra-venous infusion, day 1;Gemcitabine 800 mg/m2 in 250 mL of normal saline, given as fixed dose-rate infusion,day 1;After the administration of gemcitabine, the infusion line should be flushed with 20 ml of normal saline and then 50 ml of 5% glucose solution before the administration of oxaliplatin; Every 14 days, as one cycle.Prophylactic G-CSF or GM-CSF will not be allowed in this study. In case of grade 4 or complication neutropenia, patients may receive G-CSF according to the regulation of National Insurance Bureru treated with appropriate antibiotics. Therapeutic G-CSF may be used at the discretion of attending physicians.

Drug: S-1,Leucovorin,Oxaliplatin,Gemcitabine

Interventions

S-1,Leucovorin,Oxaliplatin,Gemcitabine DRUG

Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in metastatic pancreatic adenocarcinoma

Also known as: G-CSF

Statin dose titration

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas (mPAC).
• Patients must have no history of prior chemotherapy.
• Patients with prior radiotherapy.
• Patients' baseline ECOG performance status must be 2.
• Patients' life expectancy must be 12 weeks or greater.
• Patients' age must be 20 and 75.
• Patients must have adequate bone marrow function.
• Patients must have adequate liver and renal function.
• All patients must be sign and give written informed consent.

You may not qualify if:

• Patients who have major abdominal surgery, radiotherapy.
• Patients with central nervous system metastasis.
• Patients with active infection.
• Pregnant or breast-nursing women.
• Patients with active cardiopulmonary disease.
• Patients who have peripheral neuropathy \> Grade I.
• Patients who have serious concomitant systemic disorders.
• Patients who have other prior or concurrent malignancy.
• Patients who are under biologic treatment for their malignancy.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• National Taiwan University Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Chiang NJ, Tsai KK, Hsiao CF, Yang SH, Hsiao HH, Shen WC, Hsu C, Lin YL, Chen JS, Shan YS, Chen LT. A multicenter, phase I/II trial of biweekly S-1, leucovorin, oxaliplatin and gemcitabine in metastatic pancreatic adenocarcinoma-TCOG T1211 study. Eur J Cancer. 2020 Jan;124:123-130. doi: 10.1016/j.ejca.2019.10.023. Epub 2019 Nov 22.

  PMID: 31765987 DERIVED

MeSH Terms

Interventions

Granulocyte Colony-Stimulating Factor

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Li-Tzong Chen, Ph.D.

  National Institute of Cancer Research

  STUDY CHAIR

• Kelvin Kun-Chih Tsai, Ph.D.

  National Institute of Cancer Research

  PRINCIPAL INVESTIGATOR

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: July 6, 2011
• First Posted: August 12, 2011
• Study Start: March 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 4, 2016

Record last verified: 2011-06

Locations

TW (1)