Neoadjuvant FDR GX in Locally Advanced Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JLee, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01268384
First received: December 29, 2010
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: Gemcitabine plus Capecitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Fixed Dose Rate Gemcitabine Plus Capecitabine in Locally Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • R0 resection rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Microscopic complete resection rate after neoadjuvant chemotherapy


Secondary Outcome Measures:
  • Adverse events associated with neoadjuvant chemotherapy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    NCI CTCAE v.3.0 based AEs

  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Overall survival after enrollment


Enrollment: 43
Study Start Date: April 2006
Study Completion Date: August 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FDR_GX
Fixed dose rate gemcitabine plus capecitabine every 3 weeks for 3-9 cycles
Drug: Gemcitabine plus Capecitabine
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
Other Names:
  • Neoadjuvant chemotherapy
  • GemCap

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Concomitant or administration of any other experimental drug under investigation within 3 weeks before the study
  • Concomitant chemotherapy, hormonal therapy, or immunotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268384

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Jae-Lyun Lee, MD, PhD Asan Medical Center
  More Information

No publications provided

Responsible Party: JLee, Associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01268384     History of Changes
Other Study ID Numbers: APBCC_01
Study First Received: December 29, 2010
Last Updated: December 5, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
pancreatic cancer
neoadjuvant chemotherapy
gemcitabine
capecitabine

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 01, 2014