EUS-guided Intratumoral Gemcitabine in Locally Advanced Unresectable Pancreatic Cancer

NCT01834170 | Completed Phase 1 DMC

• 1 other identifier: DDRC 92-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause of cancer death. The only effective treatment for pancreatic cancer includes surgery. However, only 20% of the patients have surgically treatable disease. Also, the 5-year survival for the surgically treated patients is only 15%. About 40% of the patients present with advanced disease with distant metastasis, and the remaining 40% present with locally advanced unresectable cancer with the tumor invaded into surrounding major vessels. For those with locally advanced disease, systemic chemotherapy with or without radiotherapy provides palliation of the symptoms but cannot cure the disorder. Systemic chemotherapy is given through peripheral vessels. The investigators hypothesized that direct injection of the chemotherapeutic drug into the tumor may help to boost the effect of systemic chemotherapy and radiotherapy in those with locally advanced pancreatic cancer.

Conditions

Pancreatic Adenocarcinoma

Keywords

Pancreatic cancer; Pancreatic adenocarcinoma; Endoscopic ultrasound

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events as a measure of safety and tolerability

  6 months

Secondary Outcomes (1)

• Proportion of participants who remain alive one year after enrollment compared to the historical matched control group

  1 year

Study Arms (1)

Intratumoral gemcitabine injection

EXPERIMENTAL

Intratumoral injection of gemcitabine by means of endoscopic ultrasound.

Drug: Gemcitabine

Interventions

Gemcitabine DRUG

Two intratumoral injections of gemcitabine under endoscopic ultrasound (EUS)-guidance at month 0 and month 3. The patients will receive systemic chemotherapy with or without radiotherapy at the discretion of oncologist

Also known as: Gemzar

Intratumoral gemcitabine injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically verified pancreatic adenocarcinoma who have locally advanced unresectable tumor

You may not qualify if:

• Early stage resectable pancreatic cancer with the intact surrounding major vessels on imaging
• Pancreatic cancer with distant metastasis
• Unwilling to sign informed consent

Sponsors & Collaborators

• University of Tehran: lead

Study Sites (1)

Digestive Disease Research Center, Shariati ospital

Tehran, Iran

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

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

Study Officials

• Mehdi Mohamadnejad, M.D.

  Digestive Disease Research Center, University of Tehran/Medical sciences

  PRINCIPAL INVESTIGATOR

• Reza Malekzadeh, M.D.

  Digestive Disease Research Center, University of Tehran/Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 6, 2013
• First Posted: April 17, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

IR (1)