Oxaliplatin, Gemcitabine, Erlotinib, and Radiation Therapy in Treating Patients With Unresectable and/or Metastatic Pancreatic Cancer or Biliary Tract Cancer

NCT00266097 | Completed Phase 1 DMC

• 3 other identifiers: LCCC 0405P30CA016086CDR0000550061
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving oxaliplatin together with gemcitabine, erlotinib, and radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of oxaliplatin, gemcitabine, and erlotinib when given together with radiation therapy in treating patients with unresectable and/or metastatic pancreatic cancer or biliary tract cancer.

Conditions

Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Pancreatic Cancer

Keywords

stage III pancreatic cancer; stage IV pancreatic cancer; unresectable extrahepatic bile duct cancer; unresectable gallbladder cancer; adenocarcinoma of the extrahepatic bile duct; adenocarcinoma of the gallbladder; adenocarcinoma of the pancreas; recurrent pancreatic cancer; recurrent extrahepatic bile duct cancer; recurrent gallbladder cancer

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD) of oxaliplatin and gemcitabine hydrochloride (Part 1)

  The MTC of Oxaliplatin and gemcitabine is defined as the combination for which the rate of toxicities that cause dose reductions plus twice the rate of dsoe limiting toxicity (DLT) is equal to 0.5

  6 weeks

• Maximum Tolerated Dose (MTD) of erlotinib hydrochloride and gemcitabine hydrochloride (Part 2)

  The highest dose for which the observed dose reduction rate plus twice the dose limiting toxicity (DLT) rate does not exceed 0.5 will be declared the MTD

  6 weeks

Study Arms (2)

Part I

EXPERIMENTAL

Oxaliplatin + Gemcitabine + Radiation

Drug: gemcitabine hydrochloride; Drug: oxaliplatin; Radiation: radiation therapy

Part II

EXPERIMENTAL

Erlotinib + Oxaliplatin + Gemcitabine + Radiation

Drug: erlotinib hydrochloride; Radiation: radiation therapy; Drug: gemcitabine hydrochloride; Drug: Oxaliplatin

Interventions

erlotinib hydrochloride DRUG

Cohort (-1) = 50 mg daily Cohort 1 = 50mg daily Cohort 2= 75 mg daily Cohort 3 = 100mg daily Cohort 4 = 100mg daily Cohort 5 = 150mg daily

Part II

gemcitabine hydrochloride DRUG

Gemcitabine will be given at a dose of 100 mg/m2 for the first cohort and escalated to a fixed dose of 200 mg/m2 for the remaining 3 cohorts

Part I

Oxaliplatin DRUG

Oxaliplatin will be given at 30 mg/m2 weekly for the first two cohorts and then will be dose-escalated to 45 mg/m2 and 60 mg/m2 for the next 2 in cohorts

Part I

radiation therapy RADIATION

5040 cGy, every week, up to 6 weeks

Part I; Part II

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Biopsy confirmed diagnosis of any of the following: * Pancreatic carcinoma * Ampullary carcinoma * Biliary tract (gallbladder or bile duct) carcinoma * Unresectable and/or biopsy-proven metastatic disease * Suitable for bimodality therapy, as determined by a medical oncologist and radiation oncologist PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 2 months * ANC \> 1,500/mm³ * Platelet count \> 100,000/mm³ * Creatinine \< 1.5 mg/dL * Total bilirubin \< 2 times upper limit of normal (ULN) * AST \< 3 times ULN (\< 5 times ULN if liver metastases are present) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known hypersensitivity to platinum agent or gemcitabine hydrochloride * No serious medical or psychiatric illnesses that would preclude giving informed consent PRIOR CONCURRENT THERAPY: * No prior radiotherapy to the upper abdomen * More than 3 weeks since prior chemotherapy * No prior erlotinib hydrochloride * At least 5 days since prior and no concurrent CYP3A4 inducer/inhibitor

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

MeSH Terms

Conditions

Bile Duct Neoplasms; Gallbladder Neoplasms; Pancreatic Neoplasms

Interventions

Erlotinib Hydrochloride; Gemcitabine; Oxaliplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Endocrine Gland Neoplasms; 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; Therapeutics

Study Officials

• Bert H. O'Neil, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2005
• First Posted: December 15, 2005
• Study Start: August 1, 2004
• Primary Completion: March 1, 2009
• Study Completion: September 1, 2011
• Last Updated: March 7, 2012

Record last verified: 2012-03

Locations

US (1)