A Phase 1/2 interventional study of Panitumumab in Cancer, sponsored by University of Wisconsin, Madison. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-09.
Sponsored by University of Wisconsin, Madison · Phase 1/2, Interventional, and Treatment
The overall study objective is to evaluate the dose limiting toxicities and the recommended phase II dose of Panitumumab when combined with the standard of care treatment with cisplatin, fluorouracil and radiation in patients with locally advanced esophageal cancer. The investigators will also be assessing the ability of PET (Positron Emission Tomography) imaging to predict the degree of pathologic response.
All patients will have a pre-study FDG (F-18 Fluorodeoxyglucose) PET scan and will receive radiation therapy and chemotherapy over a 35 day period. 4-8 weeks post radiation and chemotherapy patients will be restaged with a PET/CT scan. It is anticipated that approximately 30 patients enrolled will undergo an esophagectomy which is considered standard of care post radiation and chemotherapy. The surgery will allow us to compare this study regimen to the historical standard of care (Cisplatin/fluorouracil chemotherapy with radiation therapy).
1,592 studies on the registry are indexed under Esophageal Neoplasms; 460 are open to participants now.
This study's enrollment of 11 is below the median of 58 across 1,170 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Panitumumab/Cisplatin/Fluorouracil and Radiation therapy 1.5mg/kg Panitumumab, 60mg/m2 cisplatin, 750mg/m2 5FU (Fluorouracil)
Drug: Panitumumab
Panitumumab/Cisplatin/Fluorouracil and Radiation therapy 1.5mg/kg Panitumumab, 80mg/m2 cisplatin, 1000mg/m2 5FU (Fluorouracil)
Drug: Panitumumab
dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.
MTD of Panitumumab in Combination With Cisplatin/Fluorouracil and Radiation for Locally Advanced Esophageal Cancer Determined by Number of Participants Experiencing DLT
Maximum Tolerated Dose (MTD) will be where 0 of 6 patients experienced Dose Limiting Toxicities (DLT) from start until 28 days after the completion of radiation. The investigator considered DLTs related to the treatment to be: grade 4 hematologic toxicity, grade 3 hematologic toxicity lasting \>7 days, any neutropenic fever, all grade 3 non-hematologic toxicities (excluding alopecia and nausea/vomiting/diarrhea if controlled with antiemetics or anti-diarrheal agents), grade 4 lab abnormality (whether symptomatic or asymptomatic), any treatment related to death, any toxicity associated with 1) any single interruption of radiation \>10 treatment days, 2) \>2 interruptions of radiation per course, 3) a delay in completion of radiation by \>14 days beyond planned treatment schedule, 4) inability to deliver \>80% of planned treatment doses, 5) any infield grade 4 toxicity
Time frame: approximately 18 weeks
Pathologic Response
From therapy initiation through 30 days post surgery. 5.5 weeks of XRT/chemo, 4-8weeks post Radiation (XRT)/Chemo subjects to undergo a surgical resection, and study will be completed 4 weeks post surgery with surgical morbidity and mortality information
Time frame: 20 weeks.
Participants were recruited from the University of Wisconsin Hospital and Clinics between 2010 and 2013.
| Milestone | Dose Level 1 | Dose Level -1 |
|---|---|---|
| Started | 5 | 6 |
| Completed | 5 | 5 |
| Not completed | 0 | 1 |
| Withdrew: Physician decision | 0 | 1 |
Maximum Tolerated Dose (MTD) will be where 0 of 6 patients experienced Dose Limiting Toxicities (DLT) from start until 28 days after the completion of radiation. The investigator considered DLTs related to the treatment to be: grade 4 hematologic toxicity, grade 3 hematologic toxicity lasting \>7 days, any neutropenic fever, all grade 3 non-hematologic toxicities (excluding alopecia and nausea/vomiting/diarrhea if controlled with antiemetics or anti-diarrheal agents), grade 4 lab abnormality (whether symptomatic or asymptomatic), any treatment related to death, any toxicity associated with 1) any single interruption of radiation \>10 treatment days, 2) \>2 interruptions of radiation per course, 3) a delay in completion of radiation by \>14 days beyond planned treatment schedule, 4) inability to deliver \>80% of planned treatment doses, 5) any infield grade 4 toxicity
| Participants | Dose Level 1 | Dose Level -1 |
|---|---|---|
| MTD of Panitumumab in Combination With Cisplatin/Fluorouracil and Radiation for Locally Advanced Esophageal Cancer Determined by Number of Participants Experiencing DLT | 2 | 0 |
From therapy initiation through 30 days post surgery. 5.5 weeks of XRT/chemo, 4-8weeks post Radiation (XRT)/Chemo subjects to undergo a surgical resection, and study will be completed 4 weeks post surgery with surgical morbidity and mortality information
No measurements were reported for this outcome.
Collected over Adverse event data were collected for up to 6 years, 3 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dose Level 1 | 0/5 (0%) | 2/5 (40%) | 5/5 (100%) |
| Dose Level -1 | 0/6 (0%) | 2/6 (33.3%) | 6/6 (100%) |
| Event | Dose Level 1 | Dose Level -1 |
|---|---|---|
| HemorrhageGastrointestinal disorders | 2/5 | 0/6 |
| PlateletsBlood and lymphatic system disorders | 2/5 | 0/6 |
| Alanine Amiotransferase (ALT)General disorders | 1/5 | 0/6 |
| Aspartate Aminotransferase (AST)General disorders | 1/5 | 0/6 |
| BilirubinGeneral disorders | 1/5 | 0/6 |
| ColitisGastrointestinal disorders | 1/5 | 0/6 |
| ConductionCardiac disorders | 1/5 | 0/6 |
| DehydrationGastrointestinal disorders | 1/5 | 1/6 |
| DiarrheaGastrointestinal disorders | 1/5 | 0/6 |
| HyperglycemiaMetabolism and nutrition disorders | 1/5 | 0/6 |
| Event | Dose Level 1 | Dose Level -1 |
|---|---|---|
| LeukocytesBlood and lymphatic system disorders | 3/5 | 6/6 |
| HemoglobinBlood and lymphatic system disorders | 5/5 | 3/6 |
| EsophagitisGastrointestinal disorders | 5/5 | 0/6 |
| AcneSkin and subcutaneous tissue disorders | 3/5 | 5/6 |
| DysphagiaGastrointestinal disorders | 4/5 | 5/6 |
| DehydrationGastrointestinal disorders | 1/5 | 5/6 |
| LymphopeniaBlood and lymphatic system disorders | 4/5 | 2/6 |
| DiarrheaGastrointestinal disorders | 4/5 | 0/6 |
| PlateletsBlood and lymphatic system disorders | 2/5 | 4/6 |
| FatigueGeneral disorders | 3/5 | 4/6 |
| Age, Categorical(Participants) | Dose Level 1 | Dose Level -1 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 3 | 6 |
| >=65 years | 2 | 3 | 5 |
| Age, Continuous(years) | Dose Level 1 | Dose Level -1 | Total |
|---|---|---|---|
| Mean | 60.3 (51 to 69) | 62.6 (53 to 69) | 61.5 (51 to 69) |
| Sex: Female, Male(Participants) | Dose Level 1 | Dose Level -1 | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 5 | 6 | 11 |
| Ethnicity (NIH/OMB)(Participants) | Dose Level 1 | Dose Level -1 | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 5 | 6 | 11 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Dose Level 1 | Dose Level -1 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 5 | 6 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Dose Level 1 | Dose Level -1 | Total |
|---|---|---|---|
| United States | 5 | 6 | 11 |
This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison