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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00591123
Recruitment Status : Completed
First Posted : January 11, 2008
Last Update Posted : November 3, 2015
University of California, Los Angeles
OSI Pharmaceuticals
Information provided by (Responsible Party):
Translational Oncology Research International

Brief Summary:

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 or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
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
Study Start Date : December 2007
Actual Primary Completion Date : June 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. To determine the safety and toxicity of the combination. [ Time Frame: 5 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00591123

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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
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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
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Responsible Party: Translational Oncology Research International Identifier: NCT00591123    
Other Study ID Numbers: TORI GI-05
BB-IND 77,805
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: October 2015
Keywords provided by Translational Oncology Research International:
Gastric Cardia
Additional relevant MeSH terms:
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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
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Growth Substances
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action