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

NCT ID: NCT00591123

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2015-09-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FOLFOX, plus 5-FU and Erlotinib

single arm

Group Type: EXPERIMENTAL

FOLFOX

Intervention Type: DRUG

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

5-FU

Intervention Type: DRUG

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

Erlotinib

Intervention Type: DRUG

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.

Interventions

FOLFOX

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

5-FU

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

Intervention Type: DRUG

Erlotinib

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.

Intervention Type: DRUG

Other Intervention Names

Leucovorin Calcium; 5-FU; Oxaliplatin; Fluorouracil

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

OSI Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Translational Oncology Research International

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zev Wainberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Fairooz Kabbinavar, MD

Role: STUDY_DIRECTOR

UCLA - TORI

J Randolph Hecht, MD

Role: STUDY_CHAIR

University of California, Los Angeles

Locations

Translational Oncology Research International (TORI) Network

Los Angeles, California, United States

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

BB-IND 77,805

Identifier Type: OTHER

Identifier Source: secondary_id

TORI GI-05

Identifier Type: -

Identifier Source: org_study_id