Esophageal CancerPhase 2NCT00836277
Phase II Study of Irinotecan and Panitumumab
A Phase 2 study testing Panitumumab and Irinotecan in people with Esophageal Cancer, run by Weijing Sun, MD, FACP at 1 site in United States.
Trial summary
This study proposes a single-arm, phase II study of irinotecan with panitumumab as second-line therapy for patients with advanced esophageal adenocarcinoma. Efficacy will be assessed by response rate, with an exploratory outcome endpoint of time to progression (as panitumumab may result in prolonged stable disease). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Panitumumab and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Aug 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
- Patients must have histologically or cytologically confirmed diagnosis of locally recurrent or metastatic adenocarcinoma of the esophagus which is incurable with standard therapy.
- Patients must have measurable disease outside a previous radiation port, or which has developed in the port since the conclusion of radiation and is biopsy-proven to be recurrent cancer.
- One prior chemotherapy regimen for metastatic disease, with the exception of prior irinotecan or panitumumab.
- Prior radiation therapy to no more than 20% of the bone marrow is allowed. No treatment with wide field radiation within 4 weeks of entry onto this study.
- Full recovery from the effects of any prior surgery.
- Man or woman >18 years of age.
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- ECOG performance status <2 (Karnofsky >60%)
- Life expectancy of >3 months
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 9.0 g/dL
- Creatinine < or = to 1.5 mg/dL
- Creatinine clearance > or = to 50 mL/min calculated by the Cockcroft-Gault method as follows:
- Male creatinine clearance = (140 - age) x (weight in Kg) / (serum Cr x 72)
- Female creatinine clearance = (140 - age) x (weight in Kg) x 0.85 / (serum Cr x 72)
- Aspartate aminotransferase (AST) < or = to 3 x ULN (if liver metastases less than or equal to 5 x ULN)
- Alanine aminotransferase (ALT) < or = to 3 x ULN (if liver metastases less than or equal to 5 x ULN)
- Total bilirubin < or = to 1.5 x ULN
- Magnesium ≥ lower limit of normal
- Potassium > or = to lower limit of normal
- Because the effects of irinotecan and panitumumab on the developing human fetus are unknown, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
Who cannot join
- History or known presence of central nervous system (CNS) metastases unless CNS metastases have been irradiated and are stable.
- 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 greater than or equal to 5 years prior to enrollment
- Pre-existing peripheral neuropathy > grade 1.
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- History of allergic reactions attributed to compounds of similar chemical or biologic composition to panitumumab or irinotecan.
- Patients receiving any medications or substances that are established or probable inhibitors or inducers of P450 3A4 are ineligible.
- Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
- Radiotherapy < or = to 14 days prior to enrollment.
- Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies (or small molecules for Phase I studies) (eg, bevacizumab)< or = to 30 days before enrollment
- Subjects requiring chronic use of immunosuppressive agents (eg, methotrexate, cyclosporine)
- Any investigational agent or therapy < or = to 30 days before enrollment
- Prior therapy with Irinotecan or panitumumab.
- 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.
- Women who test positive for serum or urine pregnancy test < 72 hours before randomization or is breast feeding
- Known positive test(s) for acute or chronic active hepatitis B infection
- Major surgery within 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 treatment and for six months after the last investigational product(s) administration
- Any underlying condition which in the opinion of the principal investigator will interfere with safety or with compliance with the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Phase II Study of Irinotecan and Panitumumab as Second-Line Therapy for Patients With Advanced Esophageal Adenocarcinoma
This study proposes a single-arm, phase II study of irinotecan with panitumumab as second-line therapy for patients with advanced esophageal adenocarcinoma. Efficacy will be assessed by response rate, with an exploratory outcome endpoint of time to progression (as panitumumab may result in prolonged stable disease). In addition to the usual safety assessments, molecular correlates will be carried out in order to search for pharmacodynamic and pharmacogenomic features that may correlate with response. Measures of host/patient immune function will be assessed by evaluating the relationship between Fc receptor polymorphisms and response in patients treated with panitumumab. Measures of EGFR protein and phosphoprotein expression by immunohistochemical- (IHC-) staining, K-ras mutation status1 and reverse-phase protein arrays (RPPA) and EGFR gene amplification by fluorescence in situ hybridization (FISH) will be assessed as exploratory correlates.
Read the detailed description
Esophageal cancer is a highly lethal malignancy that is increasing in incidence, especially the histologic subtype of adenocarcinoma. Fully 50% of patients present with advanced, incurable disease. Of the remainder who are diagnosed at curable stages, at most 30% are long-term survivors. Advances in therapy for both local and advanced disease have been stagnant in the past few decades. As such, there is an urgent need for advances in therapy. The development of modern cytotoxic chemotherapy and in particular, biologically targeted agents, provides hope for improving the outcome in these patients.
The semi-synthetic derivative of camptothecin, irinotecan, is active in esophageal adenocarcinoma, both alone and in combination with cisplatin. Use as front-line therapy in both multi-modality regimens and combination chemotherapy is common. More recently, the elucidation of the role of the epidermal growth factor receptor (EGFR) pathway in esophageal cancer has resulted in the pre-clinical and clinical study of the activity of EGFR directed agents for treatment of esophageal cancer.
The anti-EGFR antibodies, panitumumab and cetuximab, are active as both single agents and in combination with cytotoxic chemotherapy in patients with colorectal adenocarcinoma. In particular, the combination of irinotecan and cetuximab is active for irinotecan refractory colorectal cancer, while panitumumab is active compared with best supportive care. In our clinic, we have empiric evidence for the unexpectedly significant activity of the combination of cetuximab and irinotecan as third-line treatment for advanced esophageal adenocarcinoma. Panitumumab has the clinical advantages, compared with cetuximab, of being fully human,, thus resulting in a lower frequency of infusion reactions.
This recent experience with these targeted agents in solid tumors, while still promising, has yielded relatively modest results.7-11 Notably, however, retrospective analyses of clinical trials are consistently revealing that differences in treatment effect between subgroups of patients can be associated with specific molecular profiles.12-18 These findings suggest the potential for a more rational approach to trial design that would use patient and tumor characteristics to select patients for therapy, thus enriching the population of responders.
- Conditions
- Esophageal Cancer
- Being tested
- Panitumumab, Irinotecan
- Keywords
- Panitumumab, Irinotecan, Esophageal Adenocarcinoma, Phase II
- Medical subject headings
- Esophageal Neoplasms, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanitumumabDrug
Also called ABX-EGF
9mg/kg IV Day 1 Cycle = 21 days
IrinotecanDrug
Also called Camptosar, Campto, CPT-11
125mg/m2 IV Day 1 and Day 8
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan plus panitumumab | Experimental | Irinotecan 100 mg/m2 IV Day 1 and Day 8
+ Panitumumab 9mg/kg IV Day 1 Cycle = 21 days Receives: Drug: Panitumumab; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate (RR)
Response rate (RR) = the # participants with partial response (PR) + # participants with (CR) / # participants with (PR) + # participants with (CR ) + # participants with (SD) + # participants with (PD). This proportion was subsequently multiplied by 100. RECIST v1.0 criteria for Target Lesions was used: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; 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; 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
Measured: Up to 14 months
Clinical Benefit Rate (CBR)
Using RECIST v1.0 criteria, clinical benefit rate (CBR) = # participants with (PR) + # participants with (CR) + # participants with (SD) / # participants with (PR) + # participants with (CR) + # participants with (SD) + # participants with (PD). This proportion was subsequently multiplied by 100. RECIST v1.0 criteria for Target Lesions is defined as: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; 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; 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.
Measured: Up to 14 months
Secondary outcomes (3)
Progression-free Survival (PFS)
Survival time the is free of disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Up to 45 months (cohort)
Overall Survival (OS)
Measured: Up to 45 months (cohort)
1-year (Overall) Survival Rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startMay 2009
- Primary completionAug 2015
- Study completionAug 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weijing Sun, MD, FACP
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor-investigator, Weijing Sun, MD, FACP, University of Pittsburgh
- Investigators
- Weijing Sun, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836277
- Sponsor's protocol ID
- 07-161
- Status last verified
- Sep 2016
- First submitted
- 3 Feb 2009
- Last updated
- 15 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Yoon H, Karapetyan L, Choudhary A, Kosozi R, Bali GS, Zaidi AH, Atasoy A, Forastiere AA, Gibson MK. Phase II Study of Irinotecan Plus Panitumumab as Second-Line Therapy for Patients with Advanced Esophageal Adenocarcinoma. Oncologist. 2018 Sep;23(9):1004-e102. doi: 10.1634/theoncologist.2017-0657. Epub 2018 May 16.
PubMed 29769385
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Irinotecan and Panitumumab as Second-Line Therapy for Patients With Advanced Esophageal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00836277
- Acronym / sponsor ID
- 07-161
- Conditions
- Esophageal Cancer
- Keywords
- Panitumumab, Irinotecan, Esophageal Adenocarcinoma, Phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Weijing Sun, MD, FACPUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- May 2009
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Posted 15 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposes a single-arm, phase II study of irinotecan with panitumumab as second-line therapy for patients with advanced esophageal adenocarcinoma. Efficacy will be assessed by response rate, with an exploratory outcome endpoint of time to progression (as panitumumab may result in prolonged stable disease). In addition to the usual safety assessments, molecular correlates will be carried out in order to search for pharmacodynamic and pharmacogenomic features that may correlate with response. Measures of host/patient immune function will be assessed by evaluating the relationship between Fc receptor polymorphisms and response in patients treated with panitumumab. Measures of EGFR protein and phosphoprotein expression by immunohistochemical- (IHC-) staining, K-ras mutation status1 and reverse-phase protein arrays (RPPA) and EGFR gene amplification by fluorescence in situ hybridization (FISH) will be assessed as exploratory correlates.
Detailed description
Esophageal cancer is a highly lethal malignancy that is increasing in incidence, especially the histologic subtype of adenocarcinoma. Fully 50% of patients present with advanced, incurable disease. Of the remainder who are diagnosed at curable stages, at most 30% are long-term survivors. Advances in therapy for both local and advanced disease have been stagnant in the past few decades. As such, there is an urgent need for advances in therapy. The development of modern cytotoxic chemotherapy and in particular, biologically targeted agents, provides hope for improving the outcome in these patients.
The semi-synthetic derivative of camptothecin, irinotecan, is active in esophageal adenocarcinoma, both alone and in combination with cisplatin. Use as front-line therapy in both multi-modality regimens and combination chemotherapy is common. More recently, the elucidation of the role of the epidermal growth factor receptor (EGFR) pathway in esophageal cancer has resulted in the pre-clinical and clinical study of the activity of EGFR directed agents for treatment of esophageal cancer.
The anti-EGFR antibodies, panitumumab and cetuximab, are active as both single agents and in combination with cytotoxic chemotherapy in patients with colorectal adenocarcinoma. In particular, the combination of irinotecan and cetuximab is active for irinotecan refractory colorectal cancer, while panitumumab is active compared with best supportive care. In our clinic, we have empiric evidence for the unexpectedly significant activity of the combination of cetuximab and irinotecan as third-line treatment for advanced esophageal adenocarcinoma. Panitumumab has the clinical advantages, compared with cetuximab, of being fully human,, thus resulting in a lower frequency of infusion reactions.
This recent experience with these targeted agents in solid tumors, while still promising, has yielded relatively modest results.7-11 Notably, however, retrospective analyses of clinical trials are consistently revealing that differences in treatment effect between subgroups of patients can be associated with specific molecular profiles.12-18 These findings suggest the potential for a more rational approach to trial design that would use patient and tumor characteristics to select patients for therapy, thus enriching the population of responders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irinotecan plus panitumumab | Experimental | Drug: Panitumumab, Drug: IrinotecanIrinotecan 100 mg/m2 IV Day 1 and Day 8 + Panitumumab 9mg/kg IV Day 1 Cycle = 21 days |
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 locally recurrent or metastatic adenocarcinoma of the esophagus which is incurable with standard therapy.
- Patients must have measurable disease outside a previous radiation port, or which has developed in the port since the conclusion of radiation and is biopsy-proven to be recurrent cancer.
- One prior chemotherapy regimen for metastatic disease, with the exception of prior irinotecan or panitumumab.
- Prior radiation therapy to no more than 20% of the bone marrow is allowed. No treatment with wide field radiation within 4 weeks of entry onto this study.
- Full recovery from the effects of any prior surgery.
Key exclusion criteria (22 listed)
- History or known presence of central nervous system (CNS) metastases unless CNS metastases have been irradiated and are stable.
- 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 greater than or equal to 5 years prior to enrollment
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 |
|---|---|---|
| PanitumumabAlso: ABX-EGF9mg/kg IV Day 1 Cycle = 21 days | Drug | Irinotecan plus panitumumab |
| IrinotecanAlso: Camptosar, Campto, CPT-11125mg/m2 IV Day 1 and Day 8 | Drug | Irinotecan plus panitumumab |
Primary outcome
Response Rate (RR)
Time frame: Up to 14 months
Response rate (RR) = the # participants with partial response (PR) + # participants with (CR) / # participants with (PR) + # participants with (CR ) + # participants with (SD) + # participants with (PD). This proportion was subsequently multiplied by 100. RECIST v1.0 criteria for Target Lesions was used: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; 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; 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
Clinical Benefit Rate (CBR)
Time frame: Up to 14 months
Using RECIST v1.0 criteria, clinical benefit rate (CBR) = # participants with (PR) + # participants with (CR) + # participants with (SD) / # participants with (PR) + # participants with (CR) + # participants with (SD) + # participants with (PD). This proportion was subsequently multiplied by 100. RECIST v1.0 criteria for Target Lesions is defined as: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; 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; 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.
3 secondary outcomes
Progression-free Survival (PFS)
Time frame: Up to 45 months (cohort)
Overall Survival (OS)
Time frame: Up to 45 months (cohort)
1-year (Overall) Survival Rate
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29769385Yoon H, Karapetyan L, Choudhary A, Kosozi R, Bali GS, Zaidi AH, Atasoy A, Forastiere AA, Gibson MK. Phase II Study of Irinotecan Plus Panitumumab as Second-Line Therapy for Patients with Advanced Esophageal Adenocarcinoma. Oncologist. 2018 Sep;23(9):1004-e102. doi: 10.1634/theoncologist.2017-0657. Epub 2018 May 16.
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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.
Weijing Sun, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Panitumumab and Irinotecan in people with Esophageal Cancer, run by Weijing Sun, MD, FACP at 1 site 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 22 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 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 15 Nov 2016). 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?
Response Rate (RR) (time frame: Up to 14 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00836277, which also lists 1 linked publication.
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 15 Nov 2016.