Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Gastric Cardia
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
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Los Angeles, California, United States, 90095
- UCLA Jonsson Comprehensive Cancer Center
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Los Angeles, California, United States, 90095
- Translational Oncology Research International (TORI) Network
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Total Bilirubin < or = to 1.5 x ULN
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: FOLFOX, plus 5-FU and Erlotinib
single arm
|
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
Other Names:
5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home.
Other Names:
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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: 3.5 years
|
Per response evaluation criteria in solid tumors criteria (RECIST) for target lesions and assessed by computerized tomography (CT) scan. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions |
3.5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib
Time Frame: 3.5 years
|
Adverse event assessment by investigators and as reported by subjects from time of consent to 30 days after last dose.
Up to 3.5 years.
|
3.5 years
|
Collaborators and Investigators
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Adenocarcinoma
- Esophageal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Micronutrients
- Protein Kinase Inhibitors
- Vitamins
- Antidotes
- Vitamin B Complex
- Erlotinib Hydrochloride
- Fluorouracil
- Oxaliplatin
- Leucovorin
- Levoleucovorin
Other Study ID Numbers
- TORI GI-05
- BB-IND 77,805 (Other Identifier: FDA)
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