A Phase II Study of Combine Modality Therapy in Locally Advanced Pancreatic Cancer

NCT00149578 | Unknown Phase 2 DMC

• 1 other identifier: T1204
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

Induction chemotherapy will be administered every 2 weeks for 6 cycles (about 3 months). Patients who have radiological evidence of progressive disease will be shifted to salvage chemotherapy. Patients who have responsive or stable disease after induction chemotherapy will receive concurrent chemoradiotherapy 3-4 weeks after the last dose of induction chemotherapy. Surgical evaluation will be performed 4-6 weeks after the completion of chemoradiotherapy. Patients who have resectable disease will undergo surgical resection. Postoperative adjuvant chemotherapy with GOFL for 6 cycles will be given for those who have curative resection. Patients who still have unresectable disease or non-curative resection will receive systemic chemotherapy of GOFL till disease progression or unacceptable toxicity.

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; gemcitabine; oxaliplatin; 5-Fluorouracil; radiation

Outcome Measures

Primary Outcomes (2)

• The primary end point is to evaluate the local response rate after induction chemotherapy and concurrent chemoradiotherapy in locally advanced pancreatic cancer.

• chemotherapy and concurrent chemoradiotherapy in locally advanced pancreatic cancer. .

Secondary Outcomes (1)

• The secondary end points are to evaluate the distant metastasis rate and time to tumor progression, overall survival time and quality of life after induction

Interventions

Gemcitabine Oxaliplatin 5FU and Leucovorin DRUG

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed adenocarcinoma of pancreas.
• Patients must have locally advanced pancreatic cancer.
• Patients must have unresectable pancreatic cancer evaluated by radiologist and/or surgeon according to either abdominal CT or MRI, or intra-operative findings.
• Locally advanced unresectable disease was defined by CT or MRI images as low-density tumor (primary and/or lymphadenopathy) with
• extension to the celiac axis or superior mesenteric artery,
• occlusion of the superior mesenteric-portal venous confluence
• aortic, inferior vena cava (IVC) invasion or encasement
• invasion of SMV below transverse mesocolon
• rib, vertebral invasion
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan. See section 8.2 for the evaluation of measurable disease.
• Age \>20 years. Because no dosing or adverse event data are currently available on the use of study agents in patients \<20 years of age, children are excluded from this study.
• ECOG performance status 0-2; see Appendix A.
• Patients must have normal organ and marrow function as defined below:
• absolute neutrophil count \>1,500/mL
• platelets \>100,000/mL

You may not qualify if:

• Patients with distant metastases are not eligible.
• Patients may not be receiving any other investigational agents.
• Patients who have had prior chemotherapy or radiotherapy are not eligible.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in the study.
• Patients who have above grade II peripheral neuropathy.
• Patients who had non-curable second primary malignancy.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because the study agents has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study agents, breastfeeding should be discontinued if the mother is treated with the study agents.
• Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with study agent administered during the study. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.

Sponsors & Collaborators

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

Study Sites (2)

National Taiwan University Hospital

Taipei, 333, Taiwan

RECRUITING

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Leucovorin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Study Officials

• Hui-Ju Ch'ang, M.D.

  Pancreatic Cancer Disease Committee of Taiwan Cooperative Oncology Group

  STUDY CHAIR

• Li-Tzong Chen, Ph.D.

  Pancreatic Cancer Disease Committee of Taiwan Cooperative Oncology Group

  STUDY CHAIR

Central Study Contacts

Yueh-Ling Ho, RN

CONTACT

886-2-26534401; ylho@nhri.org.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 8, 2005
• Study Start: October 1, 2004
• Study Completion: October 1, 2008
• Last Updated: May 17, 2007

Record last verified: 2007-05

Locations

TW (2)