Esophageal AdenocarcinomaPhase 1/2EOXPNCT00667420
Perioperative Panitumumab and Epirubicin, Oxaliplatin and Xeloda (EOX) in Patients With Gastroesophageal Adenocarcinoma
A Phase 1/2 study testing panitumumab, epirubicin, oxaliplatin, xeloda in people with Esophageal Adenocarcinoma and Gastric Adenocarcinoma, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
A pilot study to determine the safety of using perioperative panitumumab with EOX (epirubicin, oxaliplatin, and capecitabine) in patients with adenocarcinoma of the esophagus and stomach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Adenocarcinoma, Gastric Adenocarcinoma
- What is being tested?
- panitumumab, epirubicin, oxaliplatin, xeloda
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Jun 2014
- Phase
- Phase 1/2
- 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
- Patients must have histologically or cytologically confirmed diagnosis of adenocarcinoma of the stomach, gastroesophageal junction, or lower third of the esophagus, AJCC stage II-IIIB (gastric) or IIA-IVA (esophageal). M1a disease will be included, but not T4 lesions.
- No prior radiation or chemotherapy including anti-EGFR or vascular endothelial growth factor (VEGF) antibody or tyrosine kinase inhibitor treatments.
- All patients must have staging endoscopic ultrasound (EUS) prior to enrollment.
- Men or Women >18 years of Age
- ECOG performance status <2 (Karnofsky >60%, see Appendix A).
- Cardiac ejection fraction >45% by echocardiogram or MUGA scan.
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- Must be able to either swallow pills or have gastrostomy tube in place for administration of enteral medications.
- Patients must have normal organ, metabolic and marrow function as defined below:
- Hematologic function, as follows:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 9.0 g/dL
- Renal function, as follows:
- Creatinine < or = 1.5 mg/dL x ULN
- Hepatic function, as follows:
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT)< or = 3 x ULN
- Total bilirubin < 1.5 x ULN
- Metabolic function, as follows:
- Magnesium ≥ lower limit of normal
- Calcium < or = lower limit of normal -Human IgG is known to cross the placental barrier; therefore, Panitumumab may be transmitted from the mother to the developing fetus. In women of childbearing potential, appropriate contraceptive measures must be used during treatment with panitumumab and for 6 months following the last dose of panitumumab. If panitumumab is used during pregnancy or if the patient becomes pregnant while receiving this drug, she should be apprised of the potential risk for loss of the pregnancy or potential hazard to the fetus.
- 3.1.10 Ability to understand and the willingness to sign and date a written IEC/IRB approved informed consent form.
Who cannot join
- Evidence of distant metastatic disease.
- T4 tumor on initial staging studies.
- History of another primary cancer, except:
- Curatively treated in situ cervical cancer
- Curatively resected non-melanoma skin cancer
- Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ³ 5 years prior to enrollment
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- Relative or absolute contraindications to surgery which in the opinion of the investigator make the patient a poor candidate for surgical resection.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to panitumumab or other agents used in study.
- Subjects requiring chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan.
- History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results.
- Subject unwilling or unable to comply with study requirements.
- Women who test positive for serum or urine pregnancy test < 72 hours before randomization or are breast feeding.
- Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, acute or chronic active hepatitis B infection.
- Major surgery with 28 days or minor surgery within 14 days of study enrollment.
- Men or women of child-bearing potential (women who are post-menopausal < 52 weeks, not surgically sterilized, or not abstinent) not consenting to use adequate contraception (per institutional standard of care) during the course of the study and after the last investigational product(s) administration (24 weeks for women, 4 weeks for men).
- Subjects with > grade 1 neuropathy at baseline.
- Contraindication to port-a-cath placement.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
DFCI
Boston, Massachusetts, 02115
About this study
Official title: A Pilot Study of Perioperative Panitumumab in Combination With Epirubicin, Oxaliplatin and Xeloda in Patients With Resectable Gastroesophageal Adenocarcinoma
A pilot study to determine the safety of using perioperative panitumumab with EOX (epirubicin, oxaliplatin, and capecitabine) in patients with adenocarcinoma of the esophagus and stomach.
- Conditions
- Esophageal Adenocarcinoma, Gastric Adenocarcinoma
- Being tested
- panitumumab, epirubicin, oxaliplatin, xeloda
- Keywords
- gastric, esophageal, panitumumab
- Medical subject headings
- Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
panitumumab, epirubicin, oxaliplatin, xelodaDrug
pilot study
| Study group | Role | What they receive |
|---|---|---|
| EOXP chemotherapy | Experimental | open-label, single-arm EOXP Epirubicin 50mg/m2 by IV on day 1 of each 21 day cycle, Oxaliplatin 100 mg/m2 by IV on day 1 of each 21 day cycle, Capecitabine 400 mg/m2 twice daily by mouth on days 1-21 of the 21 day cycle Panitumumab - 9mg/kg by IV on day 1 of each 21 day cycle Receives: Drug: panitumumab, epirubicin, oxaliplatin, xeloda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Safety and tolerability were measured by assessing the number of participants able to complete 3 cycles of pre-operative chemotherapy
Measured: after 3 cycles of pre-operative chemotherapy (approx 21 days per cycle)
Secondary outcomes (4)
R0 Resection Rate
percentage of participants who have microscopically negative margins (no tumor at/near the edge of what is resected) at the time of surgical resection
Measured: time of surgery = after 3 cycles (approx 63 days) of pre-operative EOX-P chemotherapy
Progression-Free Survival
measured from the first day of treatment to the day when conclusive evidence of new disease is found
Measured: up to 72 months
Pathologic Complete Response Rate
For patients who undergo complete resection, those who have no evidence of residual viable tumor in the surgical specimen will be declared to have achieved a complete pathologic response (pCR), and the overall percentage of patients with pCR will be determined.
Measured: at surgical resection, after 3 cycles pre-operative chemotherapy (approx 63 days)
Overall Survival
Overall survival (OS) is the duration from start of treatment to time of death from any cause.
Measured: duration from enrollment to death (up to 6 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2011
- Study completionJun 2014
Why it stopped: Closed due to slow accrual
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 Esophageal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Patrick Ryan, MD, Massachusetts General Hospital
- Investigators
- David P Ryan, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667420
- Sponsor's protocol ID
- 07326
- Acronym
- EOXP
- Status last verified
- Jul 2014
- First submitted
- 24 Apr 2008
- Last updated
- 4 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Perioperative Panitumumab in Combination With Epirubicin, Oxaliplatin and Xeloda in Patients With Resectable Gastroesophageal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00667420
- Acronym / sponsor ID
- EOXP / 07326
- Conditions
- Esophageal Adenocarcinoma, Gastric Adenocarcinoma
- Keywords
- gastric, esophageal, panitumumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to slow accrual
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Apr 2008 (estimated)
- Results
- Posted 4 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot study to determine the safety of using perioperative panitumumab with EOX (epirubicin, oxaliplatin, and capecitabine) in patients with adenocarcinoma of the esophagus and stomach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EOXP chemotherapy | Experimental | Drug: panitumumab, epirubicin, oxaliplatin, xelodaopen-label, single-arm EOXP Epirubicin 50mg/m2 by IV on day 1 of each 21 day cycle, Oxaliplatin 100 mg/m2 by IV on day 1 of each 21 day cycle, Capecitabine 400 mg/m2 twice daily by mouth on days 1-21 of the 21 day cycle Panitumumab - 9mg/kg by IV on day 1 of each 21 day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must have histologically or cytologically confirmed diagnosis of adenocarcinoma of the stomach, gastroesophageal junction, or lower third of the esophagus, AJCC stage II-IIIB (gastric) or IIA-IVA (esophageal). M1a disease will be included, but not T4 lesions.
- No prior radiation or chemotherapy including anti-EGFR or vascular endothelial growth factor (VEGF) antibody or tyrosine kinase inhibitor treatments.
- All patients must have staging endoscopic ultrasound (EUS) prior to enrollment.
- Men or Women >18 years of Age
- ECOG performance status <2 (Karnofsky >60%, see Appendix A).
Key exclusion criteria (19 listed)
- Evidence of distant metastatic disease.
- T4 tumor on initial staging studies.
- History of another primary cancer, except:
- Curatively treated in situ cervical cancer
- Curatively resected non-melanoma skin cancer
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 |
|---|---|---|
| panitumumab, epirubicin, oxaliplatin, xelodapilot study | Drug | EOXP chemotherapy |
Primary outcome
Safety and Tolerability
Time frame: after 3 cycles of pre-operative chemotherapy (approx 21 days per cycle)
Safety and tolerability were measured by assessing the number of participants able to complete 3 cycles of pre-operative chemotherapy
4 secondary outcomes
R0 Resection Rate
Time frame: time of surgery = after 3 cycles (approx 63 days) of pre-operative EOX-P chemotherapy
Progression-Free Survival
Time frame: up to 72 months
Pathologic Complete Response Rate
Time frame: at surgical resection, after 3 cycles pre-operative chemotherapy (approx 63 days)
Overall Survival
Time frame: duration from enrollment to death (up to 6 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2014.
- 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.
David P Ryan, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing panitumumab, epirubicin, oxaliplatin, xeloda in people with Esophageal Adenocarcinoma and Gastric Adenocarcinoma, run by Massachusetts General Hospital 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 21 inclusion and 19 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: stopped early, as of the sponsor's last update on 4 Jul 2014. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 4 Jul 2014). 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?
Safety and Tolerability (time frame: after 3 cycles of pre-operative chemotherapy (approx 21 days per cycle)). 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 4 Jul 2014.