Oxaliplatin, Gemcitabine, and Erlotinib Study in Patients With Advanced Chemo-naïve Pancreatic Cancer

NCT00636883 | Terminated Phase 2 DMC

• 1 other identifier: RC07/031
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the combination of Gemcitabine, Oxaliplatin and Erlotinib in the treatment of patients with pancreatic cancer will provide increased clinical benefits and improvement in their quality of life.

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Response rate (partial and complete response, stable disease, and progressive disease)

  Tumor response will be assessed following the induction therapy and after cycle 4,8 and at the end of the treatment.

Secondary Outcomes (1)

• Overall survival

  UNMEASURABLE

Interventions

Gemcitabine DRUG

GEMOX-Erlotinib consists of erlotinib 100 mg orally daily starting day 1, Gemcitabine 1000 mg/m2 in 10 mg/m2/min (100 minutes) infusion on day 1 followed on day 2 by oxaliplatin 100 mg/m2 in a 2-hour infusion. Treatment will be repeated every 2 weeks. Each two weeks is a cycle.If at end of 12 cycles response continues, will administer Gemox and erlotinib till achieve maximum response. Then start Erlotinib maintenance therapy.

Also known as: Oxaliplatin, Erlotinib

Eligibility Criteria

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

You may qualify if:

• Patient's age between 18 and 75 years.
• Presence of microscopic diagnosis of pancreatic cancer.
• The disease is Locally advanced deemed by the surgeon to be unresectable, or metastatic disease.
• Karnofsky Performance status \>50%.
• Prior radiotherapy for local diseases is allowed provided disease progression had been documented, and treatment completed at least 4 weeks before random assignment
• Prior chemotherapy is not permitted, except for fluorouracil given concurrently as a radiosensitizer.
• Patients must have normal organ function evidenced by
• Cr \<1.5 ULN
• ANC \>1000
• platelets\> 100,000
• total bilirubin \<1.5ULN.
• Pain should be controlled for at least two weeks without an increase in the narcotic consumption.
• Biliary obstruction should be controlled for at least two weeks evident by stable or improving liver function tests especially total bilirubin.
• Patient has signed a Patient Informed Consent Form.
• For all females of childbearing potential, a negative pregnancy test must be obtained within 72 hours before starting therapy.

You may not qualify if:

• Contraindication to chemotherapy.
• Evidence of uncontrolled CNS disease (patients with controlled CNS disease for 4 weeks using the same imaging method and for whom are off steroid will be eligible)
• Uncontrolled Nausea and Vomiting
• Diagnosis of other malignancy in the last 5 years excluding non-melanoma skin cancer and in -situ cervical cancer.
• Subjects unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow- up visits and unlikelihood of completing the study.
• Any known history of hypersensitivity to the study drugs.
• Pregnant or lactating women.
• Participation in a clinical trial with any investigational drug used with curative intent and within 30 days prior to study entry
• Peripheral sensitive neuropathy with functional impairment prior to study entry.

Sponsors & Collaborators

• National Guard Health Affairs: lead

Study Sites (1)

National Guard Health Affairs

Riyadh, 9661, Saudi Arabia

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Oxaliplatin; Erlotinib Hydrochloride

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; Coordination Complexes; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Abdul-Rahman M Jazieh, MD,MPH

  National Guard Hospital Affairs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Research Coordinator

Study Record Dates

• First Submitted: March 8, 2008
• First Posted: March 17, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

SA (1)