Neoadjuvant FDR GX in Locally Advanced Pancreatic Cancer

NCT01268384 | Completed Phase 2

• 1 other identifier: APBCC_01
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The rationale for phase II trial of neoadjuvant fixed dose rate gemcitabine plus capecitabine for patients with LAPC includes the following: First, obtaining a sufficient tumor down-staging to procure R0/R1 resection, reported to be one of the most significant prognostic factors for survival; second, providing an observation period to exclude from surgery those patients with rapidly progressive disease there by to help select patients for surgery who have the greatest likelihood of a favorable postoperative outcome; third, eliminating micrometastatic disease, that is likely present in most patients, earlier than adjuvant setting and preventing post-surgical growth spurts; fourth, adjuvant therapy given in the neoadjuvant setting is better tolerated, as the patient has not recently undergone a major operation; and the last, the lack of widely accepted optimal preoperative or palliative approach in patients with LAPC, the majority of whom may not be operated on. The primary goal is to determine the R0 resection rate of the neoadjuvant fixed dose rate (FDR) gemcitabine-capecitabine combination chemotherapy in patients with borderline resectable or unresectable locally advanced pancreatic adenocarcinoma. The secondary goals are to assess progression-free survival (PFS) and OS (overall survival) in these patients and to assess adverse events of these neoadjuvant treatments.

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; neoadjuvant chemotherapy; gemcitabine; capecitabine

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  Microscopic complete resection rate after neoadjuvant chemotherapy

  6 months

Secondary Outcomes (2)

• Adverse events associated with neoadjuvant chemotherapy

  6 months

• Overall survival

  2 years

Study Arms (1)

FDR_GX

EXPERIMENTAL

Fixed dose rate gemcitabine plus capecitabine every 3 weeks for 3-9 cycles

Drug: Gemcitabine plus Capecitabine

Interventions

Gemcitabine plus Capecitabine DRUG

Gemcitabine 1,250 mg/m2 mixed with 0.9% saline 500 ml i.v. for 10 mg/m2/min on D1 and D8 Capecitabine 950 mg/m2 b.i.d. po from D1 to D14 every 21 days

Also known as: Neoadjuvant chemotherapy, GemCap

FDR_GX

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically documented pancreatic adenocarcinoma
• Clinical T3 or T4 tumor according to AJCC staging system
• Tumors considered as borderline resectable or unresectable disease assessed by multidisciplinary team including pancreatic surgeon, gastroenterologist specializing in pancreas, medical oncologist, and radiation oncologist
• Age 18 years or older
• ECOG performance status 2 or less
• Adequate organ function
• Adequate bone marrow function (WBCs\> 3,500/µL, absolute neutrophil count \[ANC\]\> 1,500/µL, hemoglobin \> 9.0 g/dL, and platelets \> 100,000/µL)
• Adequate kidney function (creatinine \< 1.5 mg/dL)
• Adequate liver function (bilirubin \< 1.5 mg/dL \[\<2.5 mg/dL for patients with obstructive jaundice due to pancreatic cancer with adequate decompression\], transaminases levels \< 3 times the upper normal limit)
• Patients must not have psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with this study
• Women of childbearing potential must have a negative pregnancy test on admission. Post-menopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Men and women of reproductive potential must have agreed to use an effective method of contraception while on treatment and for 6 months after study treatment
• The patient must be able to understand the study and has given written informed consent to participate in the study

You may not qualify if:

• Other tumor type than adenocarcinoma
• Evidence of gastrointestinal bleeding or obstruction
• Presence of the clinically relevant ascites or distant metastases
• Past or concurrent history of malignant neoplasm, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
• Pregnant or lactating women, women of childbearing potential not employing adequate contraception
• Hypersensitivity to any of the study drugs or ingredients
• Other serious illness or medical conditions
• Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
• History of significant neurologic or psychiatric disorders including dementia or seizures
• Active uncontrolled infection
• Pre-existing clinically significant diarrhea
• Active peptic ulcer
• Severe hypercalcemia of 12 mg/dL uncontrolled with bisphosphonates
• Active disseminated intravascular coagulation
• Other serious underlying medical conditions which could impair the ability of the patient to participate in the study

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Capecitabine; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Combined Modality Therapy; Therapeutics

Study Officials

• Jae-Lyun Lee, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 29, 2010
• First Posted: December 30, 2010
• Study Start: April 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2011
• Last Updated: December 6, 2011

Record last verified: 2011-12

Locations

KR (1)