Unresectable Adenocarcinoma of the EsophagusPhase 2NCT00591123
Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Gastric Cardia
A Phase 2 study testing FOLFOX, 5-FU and Erlotinib in people with Unresectable Adenocarcinoma of the Esophagus and Metastatic Adenocarcinoma of the Esophagus, run by Translational Oncology Research International at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Adenocarcinoma of the Esophagus, Metastatic Adenocarcinoma of the Esophagus, Unresectable Adenocarcinoma of Gastric Cardia
- What is being tested?
- FOLFOX, 5-FU and Erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2007to Sep 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Translational Oncology Research International (TORI) Network
Los Angeles, California, 90095
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
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
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
- Medical subject headings
- Adenocarcinoma Of Esophagus, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXDrug
Also called Leucovorin Calcium, 5-FU, Oxaliplatin
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-FUDrug
Also called Fluorouracil
5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home.
ErlotinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX, plus 5-FU and Erlotinib | Experimental | single arm Receives: Drug: FOLFOX; Drug: 5-FU; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3.5 years
Secondary outcomes (1)
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.
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionJun 2011
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Unresectable Adenocarcinoma of the EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Oncology Research International
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Sanofi, OSI Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Zev Wainberg, MD, Principal investigator, University of California, Los AngelesFairooz Kabbinavar, MD, Study director, UCLA - TORIJ Randolph Hecht, MD, Study chair, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591123
- Sponsor's protocol ID
- TORI GI-05
- Other IDs
- BB-IND 77,805
- Status last verified
- Feb 2016
- First submitted
- 28 Dec 2007
- Last updated
- 1 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00591123
- Acronym / sponsor ID
- TORI GI-05
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Translational Oncology Research InternationalUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Sanofi, OSI Pharmaceuticals
- Study start
- Dec 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Posted 1 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFOX, plus 5-FU and Erlotinib | Experimental | Drug: FOLFOX, Drug: 5-FU, Drug: Erlotinibsingle arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOLFOXAlso: Leucovorin Calcium, 5-FU, OxaliplatinOnce 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 | Drug | FOLFOX, plus 5-FU and Erlotinib |
| 5-FUAlso: Fluorouracil5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. | Drug | FOLFOX, plus 5-FU and Erlotinib |
| ErlotinibAll 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. | Drug | FOLFOX, plus 5-FU and Erlotinib |
Primary outcome
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
1 secondary outcome
Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib
Time frame: 3.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zev Wainberg, MD principal investigator
University of California, Los Angeles
Fairooz Kabbinavar, MD study director
UCLA - TORI
J Randolph Hecht, MD study chair
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFOX, 5-FU and Erlotinib in people with Unresectable Adenocarcinoma of the Esophagus and Metastatic Adenocarcinoma of the Esophagus, run by Translational Oncology Research International at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.