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

Phase 2

Completed

• Conditions: Unresectable Adenocarcinoma of the Esophagus; Metastatic Adenocarcinoma of the Esophagus; Metastatic Adenocarcinoma of Gastric Cardia; Unresectable Adenocarcinoma of Gastric Cardia
• Interventions: Drug: FOLFOX; Drug: 5-FU; Drug: Erlotinib

• Registration Number: NCT00591123
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-28
• Study First Submitted QC: 2007-12-28
• Study First Posted: 2008-01-11
• Primary Completion: 2011-06
• Study Completion: 2015-09
• Results First Submitted: 2016-01-29
• Status Verified: 2016-02
• Results First Submitted QC: 2021-09-03
• Last Update Submitted: 2021-09-03
• Results First Posted: 2021-10-01
• Last Update Posted: 2021-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FOLFOX, plus 5-FU and Erlotinib	FOLFOX	single arm
FOLFOX, plus 5-FU and Erlotinib	Erlotinib	single arm
FOLFOX, plus 5-FU and Erlotinib	5-FU	single arm

Primary Outcome Measures

Name	Time	Method
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.	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

Secondary Outcome Measures

Name	Time	Method
Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib	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.

Trial Locations

Locations (2)

UCLA Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Translational Oncology Research International (TORI) Network; 🇺🇸 Los Angeles, California, United States