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

NCT00591123 | Completed Phase 2 Results DMC

• 2 other identifiers: TORI GI-05BB-IND 77,805
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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

Keywords

Unresectable; Metastatic; Esophagus; Gastric Cardia

Outcome Measures

Primary Outcomes (1)

• 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

  3.5 years

Secondary Outcomes (1)

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

  3.5 years

Study Arms (1)

FOLFOX, plus 5-FU and Erlotinib

EXPERIMENTAL

single arm

Drug: FOLFOX; Drug: 5-FU; Drug: Erlotinib

Interventions

FOLFOX 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

Also known as: Leucovorin Calcium, 5-FU, Oxaliplatin

FOLFOX, plus 5-FU and Erlotinib

5-FU DRUG

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

Also known as: Fluorouracil

FOLFOX, plus 5-FU and Erlotinib

Erlotinib 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.

FOLFOX, plus 5-FU and Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Translational Oncology Research International: lead
• University of California, Los Angeles: collaborator
• Sanofi: collaborator
• OSI Pharmaceuticals: collaborator

Study Sites (2)

Translational Oncology Research International (TORI) Network

Los Angeles, California, 90095, United States

Location

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus; Neoplasm Metastasis

Interventions

Folfox protocol; Leucovorin; Fluorouracil; Oxaliplatin; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Quinazolines

Results Point of Contact

• Title: Zev Wainberg, MD
• Organization: UCLA GI Oncology Program, David Geffen School of Medicine at UCLA

zwainberg@mednet.ucla.edu

310-829-5471

Study Officials

• Zev Wainberg, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Fairooz Kabbinavar, MD

  UCLA - TORI

  STUDY DIRECTOR

• J Randolph Hecht, MD

  University of California, Los Angeles

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 11, 2008
• Study Start: December 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2015
• Last Updated: October 1, 2021
• Results First Posted: October 1, 2021

Record last verified: 2016-02

Locations

US (2)