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

Primary Purpose

Unresectable Adenocarcinoma of the Esophagus, Metastatic Adenocarcinoma of the Esophagus, Unresectable Adenocarcinoma of Gastric Cardia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

FOLFOX

5-FU

Erlotinib

About this trial

This is an interventional treatment trial for Unresectable Adenocarcinoma of the Esophagus focused on measuring Unresectable, Metastatic, Esophagus, Gastric Cardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Translational Oncology Research International (TORI) Network
UCLA Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FOLFOX, plus 5-FU and Erlotinib

Arm Description

single arm

Outcomes

Primary Outcome Measures

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.

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

Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib

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.

Full Information

NCT ID

NCT00591123

First Posted

December 28, 2007

Last Updated

September 3, 2021

Sponsor

Translational Oncology Research International

Collaborators

University of California, Los Angeles, Sanofi, OSI Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00591123

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Translational Oncology Research International

Collaborators

University of California, Los Angeles, Sanofi, OSI Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unresectable Adenocarcinoma of the Esophagus, Metastatic Adenocarcinoma of the Esophagus, Unresectable Adenocarcinoma of Gastric Cardia, Metastatic Adenocarcinoma of Gastric Cardia

Keywords

Unresectable, Metastatic, Esophagus, Gastric Cardia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FOLFOX, plus 5-FU and Erlotinib

Arm Type

Experimental

Arm Description

single arm

Intervention Type

Drug

Intervention Name(s)

FOLFOX

Other Intervention Name(s)

Leucovorin Calcium, 5-FU, Oxaliplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

5-FU

Other Intervention Name(s)

Fluorouracil

Intervention Description

5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home.

Intervention Type

Drug

Intervention Name(s)

Erlotinib

Intervention Description

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.

Primary Outcome Measure Information:

Title

Description

Time Frame

3.5 years

Secondary Outcome Measure Information:

Title

Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib

Description

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.

Time Frame

3.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zev Wainberg, MD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fairooz Kabbinavar, MD

Organizational Affiliation

UCLA - TORI

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

J Randolph Hecht, MD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Study Chair

Facility Information:

Facility Name

Translational Oncology Research International (TORI) Network

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

UCLA Jonsson Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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