Phase 2 Study of Erlotinib, Gemcitabine and Oxaliplatin Combination Chemotherapy to Advanced Pancreatic Cancer

NCT01505413 | Completed Phase 2 DMC

• 1 other identifier: Yun-11349
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Erlotinib is an orally available, reversible tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR). Association of chemoresistance with the activity of certain tyrosine kinases (e.g. ErbB-1 and Src) has been described for pancreatic cancer and makes a strong case for combining gemcitabine with tyrosine kinase inhibitors. In a phase III trial, the addition of erlotinib to gemcitabine improved survival compared with gemcitabine alone in advanced pancreatic cancer (MJ Moor et al). Also, gemcitabine in combination with oxaliplatin is superior to gemcitabine alone in terms of progression free survival and response rate in one phase III trial (Louvet et al). Taken together, combining erlotinib with gemcitabine and oxaliplatin may further improve the overall survival and clinical benefit of advanced pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

advanced unresectable or metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Response rate

  Responses are assessed every 2 cycles according to RECIST; the imaging tests are performed in a week preceding the corresponding cycles, and can also be repeated at any other time if clinically indicated, for example, to confirm disease progression. At any time, patients with progressive disease are withdrawn.

  24 months (01/2011 and end of study 01/2013)

Secondary Outcomes (2)

• disease control rate(SD,PR,CR)

  24 months (01/2011 and end of study 01/2013)

• Overall survival

  1 year

Study Arms (1)

Tarceva, Gemcitabine, Oxaliplatin

EXPERIMENTAL

* Erlotinib 100 mg po qd daily AND * Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1 * Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2 Every 2 weeks Each two weeks is a cycle. If at end of 12 cycles response continues, will administer Gemcitabine and erlotinib until progression.

Drug: Erlotinib; Drug: Gemcitabine; Drug: Oxaliplatin

Interventions

Erlotinib DRUG

Erlotinib 100 mg po qd daily

Also known as: tarceva

Tarceva, Gemcitabine, Oxaliplatin

Gemcitabine DRUG

Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1

Also known as: gemza, gemcibine

Tarceva, Gemcitabine, Oxaliplatin

Oxaliplatin DRUG

Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2

Also known as: oxalitin

Tarceva, Gemcitabine, Oxaliplatin

Eligibility Criteria

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

You may qualify if:

• Age over 18 years
• ECOG performance status of ≤2
• Histologically confirmed adenocarcinoma of the pancreas
• The disease is Locally advanced deemed by the surgeon to be unresectable, or metastatic disease.
• Prior chemotherapy is not permitted, except for fluorouracil given concurrently as a radiosensitizer.
• Patients must have normal organ function evidenced by
• Number of absolute neutrophil counts (ANC) \> 1.5 x 109/L
• Number of thrombocytes \> 100 x 109/L
• Total bilirubin \< 1.5 x upper limit of normal (although patients with a Total bilirubin count between 1.5 and 3 x upper limit of normal in whom a decrease is anticipated, ex. Biliary stent insertion)ALAT, ASAT \< 3 x upper limit of normal (in case of liver metastasis, 5 x upper limit of normal)
• Alkaline phosphatase \< 3 x upper limit of normal (in case of liver metastasis, 5 x upper limit of normal)
• 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.
• Is able to take medications orally

You may not qualify if:

• Tumor type other than adenocarcinoma
• 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.
• Symptomatic peripheral sensory neuropathy (NCI CTCAE v3.0 ≥ grade 2)
• Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection
• Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks before being included in the study.

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 420-767, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Erlotinib Hydrochloride; Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Kyu Taek Lee, Dr

  Soonchunhyang University Hospital

  STUDY DIRECTOR

• Hee Sook Park, Dr

  Soonchunhyang University Hospital

  STUDY DIRECTOR

• Dae Sik Hong, Dr

  Soonchunhyang University Hospital

  STUDY DIRECTOR

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: Division of Oncology-Hematology Department of Internal medicine

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: January 6, 2012
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: April 3, 2014

Record last verified: 2014-04

Locations

KR (1)