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Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Gastric Cardia

This study has been completed.
University of California, Los Angeles
OSI Pharmaceuticals
Information provided by (Responsible Party):
Translational Oncology Research International Identifier:
First received: December 28, 2007
Last updated: October 30, 2015
Last verified: October 2015

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: None (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:

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 ]

Secondary Outcome Measures:
  • To determine the safety and toxicity of the combination. [ Time Frame: 5 years ]

Enrollment: 38
Study Start Date: December 2007
Primary Completion Date: June 2011 (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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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
  2. 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.
  3. Previously untreated with chemotherapeutic agents for unresectable or metastatic disease.
  4. Adjuvant chemotherapy and/or radiotherapy are allowed as long as no oxaliplatin was used in the past 12 months.
  5. ECOG performance status 0 or 1
  6. Age > 18 years old.
  7. Life expectancy greater than 6 months.
  8. Peripheral neuropathy: must be < grade 1
  9. Absolute neutrophil count > 1,500/mm3
  10. Hemoglobin > 9.0 g/dl
  11. Platelet count > 100,000/mm3
  12. 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).
  13. 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)

  14. Women of childbearing potential must have a negative pregnancy test by urine or serum testing.
  15. 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.
  16. Patients must have signed IRB approved informed consent
  17. Patients must have the ability to comply with study and follow-up procedures.

Exclusion Criteria:

  1. Patients with known hypersensitivity to any components of oxaliplatin, leucovorin, 5-fluorouracil (or other fluoropyrimidines) or erlotinib.
  2. Women who are breast-feeding or pregnant.
  3. Presence of > Grade 2 neuropathy
  4. Patients with prior malignancy other than non-melanoma skin cancer or cervical carcinoma in situ within the past five years
  5. Current or prior history of central nervous system or brain metastases
  6. Any other medical conditions, which, in the opinion of the investigator, would preclude subjects to participate in the study.
  7. Patients who have received chemotherapy, surgery or radiation therapy within 30 days prior to the first dose.
  8. INR greater than 3.5 for patients on warfarin
  9. Known HIV infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00591123

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
OSI Pharmaceuticals
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

Responsible Party: Translational Oncology Research International Identifier: NCT00591123     History of Changes
Other Study ID Numbers: TORI GI-05
BB-IND 77,805
Study First Received: December 28, 2007
Last Updated: October 30, 2015

Keywords provided by Translational Oncology Research International:
Gastric Cardia

Additional relevant MeSH terms:
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 21, 2017