Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer

NCT00063947 | Completed Phase 1

• 6 other identifiers: NCI-2012-0143903-031NCI-5441CDR0000305855MSKCC-03031U01CA069856
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial is studying the side effects and best dose of erlotinib when given together with gemcitabine and radiation therapy in treating patients with locally advanced unresectable pancreatic cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining erlotinib with gemcitabine may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.

Conditions

Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage II Pancreatic Cancer; Stage III Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum-tolerated dose (MTD) of erlotinib hydrochloride based on the incidence of dose-limiting toxicity (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

  7.5 weeks

Secondary Outcomes (4)

• Toxicity as assessed by CTCAE version 3.0

  7.5 weeks

• Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)

  Up to 6 years

• Progression-free survival as assessed by RECIST

  From the time of study enrollment until progression of disease is documented, assessed up to 6 years

• Overall survival

  From the time of study enrollment until the date of death, assessed up to 6 years

Study Arms (1)

Treatment (radiotherapy, gemcitabine, erlotinib hydrochloride)

EXPERIMENTAL

Chemoradiotherapy: Patients undergo radiotherapy 5 days a week for 5.5 weeks. Beginning on day 1 and continuing concurrently with radiotherapy, patients receive gemcitabine IV over 30 minutes twice weekly and oral erlotinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable or responsive disease proceed to maintenance therapy. Maintenance therapy: Beginning 4-7 weeks after the completion of chemoradiotherapy, patients receive maintenance chemotherapy comprising gemcitabine IV over 30 minutes on days 1 and 8 and oral erlotinib once daily. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.

Drug: erlotinib hydrochloride; Drug: gemcitabine hydrochloride; Radiation: radiation therapy; Other: laboratory biomarker analysis

Interventions

erlotinib hydrochloride DRUG

Given orally

Also known as: CP-358,774, erlotinib, OSI-774

Treatment (radiotherapy, gemcitabine, erlotinib hydrochloride)

gemcitabine hydrochloride DRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

Treatment (radiotherapy, gemcitabine, erlotinib hydrochloride)

radiation therapy RADIATION

Undergo radiotherapy

Also known as: irradiation, radiotherapy, therapy, radiation

Treatment (radiotherapy, gemcitabine, erlotinib hydrochloride)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (radiotherapy, gemcitabine, erlotinib hydrochloride)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas
• Locally advanced, unresectable disease, defined by all of the following:
• Obvious encasement of the celiac, hepatic, or superior mesenteric artery
• Encasement of the portal or superior mesenteric vein not amenable to surgical resection
• Extrapancreatic extension with or without regional lymph node involvement
• No evidence of distant metastatic disease by staging laparoscopy\*
• Locally recurrent disease after prior curative surgery allowed provided the following are true:
• No prior chemotherapy or radiotherapy
• No evidence of distant metastatic disease by staging laparoscopy\*
• No islet cell pancreatic cancer or lymphoma or sarcoma of the pancreas
• Measurable or evaluable disease
• Primary pancreatic tumor is considered evaluable and not measurable disease
• Lymph node mass considered measurable disease
• No known brain metastases
• Performance status - ECOG 0-2

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Erlotinib Hydrochloride; Gemcitabine; Radiotherapy; Radiation

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; Therapeutics; Physical Phenomena

Study Officials

• Eileen O'Reilly

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2003
• First Posted: July 9, 2003
• Study Start: May 1, 2003
• Primary Completion: February 1, 2009
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

US (1)