Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Gastric Cardia - Full Text View

Purpose

In this study, Erlotinib and 5-Fluorouracil (5-FU), Leucovorin and Oxaliplatin (a regimen known also as FOLFOX-6) will be the chemotherapy study drugs. The main purpose of this study is to test the safety and effectiveness of this combination of chemotherapy drugs and to see how they affect your cancer.

Another purpose of this study is to examine samples from your blood and tumor. This research will be done to better understand how subjects respond to treatment. Specifically, researchers will look at the way your genes and proteins respond to drugs like those used in this study.

Condition	Intervention	Phase
Unresectable Adenocarcinoma of the Esophagus Metastatic Adenocarcinoma of the Esophagus Unresectable Adenocarcinoma of Gastric Cardia Metastatic Adenocarcinoma of Gastric Cardia	Drug: FOLFOX and Erlotinib	Phase 2

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Erlotinib and Modified FOLFOX-6 (5-Fluorouracil, Leucovorin and Oxaliplatin) in Previously Untreated Patients With Unresectable or Metastatic Adenocarcinoma of the Esophagus and Gastric Cardia

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer

Drug Information available for: Fluorouracil Leucovorin calcium Oxaliplatin Levoleucovorin Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by Translational Oncology Research International:

Primary Outcome Measures:

To determine the overall response rate of previously-untreated patients with unresectable or metastatic adenocarcinomas of the upper gastrointestinal tract when treated with the combination of 5-fluorouracil, leucovorin, oxaliplatin, and erlotinib. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the safety and toxicity of the combination. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	38
Study Start Date:	April 2008
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: single arm	Drug: FOLFOX and Erlotinib Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions, after which 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary. Other Names: Leucovorin 5-FU Oxaliplatin

Arms

Assigned Interventions

Experimental: single arm

Drug: FOLFOX and Erlotinib

Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions, after which 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.

Other Names:

Leucovorin
5-FU
Oxaliplatin

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Metastatic or unresectable adenocarcinoma of the upper gastrointestinal tract that can be measured in at least one dimension according to RECIST criteria by CT or MRI
Gastric adenocarcinomas may be included if the primary tumor arises within 5 cm of the anatomic gastro-esophageal junction (distal esophagus) or from the gastric cardia as indicated by either endoscope or imaging.
Previously untreated with chemotherapeutic agents for unresectable or metastatic disease.
Adjuvant chemotherapy and/or radiotherapy are allowed as long as no oxaliplatin was used in the past 12 months.
ECOG performance status 0 or 1
Age > 18 years old.
Life expectancy greater than 6 months.
Peripheral neuropathy: must be < grade 1
Absolute neutrophil count > 1,500/mm3
Hemoglobin > 9.0 g/dl
Platelet count > 100,000/mm3
Hepatic Function:
1. Total Bilirubin < or = to 1.5 x ULN
2. AST and ALT must be < or = to 3.0 x ULN (< or = to 5.0 x ULN if there is liver metastasis).
Creatinine clearance of > 60 ml/min as calculated by the Cockcroft Gault formula. (Ccr = ((140-Age) X Wt (kg))/ (72 X SCr (mg/100ml) for males).

(Ccr = ((140-Age) X Wt (kg))/ (72 X SCr (mg/100ml) x 0.85 for females)
Women of childbearing potential must have a negative pregnancy test by urine or serum testing.
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 4 months after the last treatment.
Patients must have signed IRB approved informed consent
Patients must have the ability to comply with study and follow-up procedures.

Exclusion Criteria:

Patients with known hypersensitivity to any components of oxaliplatin, leucovorin, 5-fluorouracil (or other fluoropyrimidines) or erlotinib.
Women who are breast-feeding or pregnant.
Presence of > Grade 2 neuropathy
Patients with prior malignancy other than non-melanoma skin cancer or cervical carcinoma in situ within the past five years
Current or prior history of central nervous system or brain metastases
Any other medical conditions, which, in the opinion of the investigator, would preclude subjects to participate in the study.
Patients who have received chemotherapy, surgery or radiation therapy within 30 days prior to the first dose.
INR greater than 3.5 for patients on warfarin
Known HIV infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591123

Locations

United States, California
Translational Oncology Research International (TORI) Network
Los Angeles, California, United States, 90095
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095

Sponsors and Collaborators

Translational Oncology Research International

University of California, Los Angeles

Sanofi

OSI Pharmaceuticals

Investigators

Principal Investigator:	Zev Wainberg, MD	University of California, Los Angeles
Study Director:	Fairooz Kabbinavar, MD	UCLA - TORI
Study Chair:	J Randolph Hecht, MD	University of California, Los Angeles

More Information

No publications provided

Responsible Party:	Zev Wainberg, MD, TORI
ClinicalTrials.gov Identifier:	NCT00591123 History of Changes
Other Study ID Numbers:	TORI GI-05, BB-IND 77,805
Study First Received:	December 28, 2007
Last Updated:	July 26, 2010
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by Translational Oncology Research International:

Unresectable
Metastatic
Esophagus
Gastric Cardia

Additional relevant MeSH terms:

Adenocarcinoma
Adenocarcinoma, Mucinous
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

Leucovorin
Levoleucovorin
Oxaliplatin
Erlotinib
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013