Colorectal CancerPhase 1NCT00004879
Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer
A Phase 1 study testing panitumumab in people with Colorectal Cancer and Esophageal Cancer, run by Jonsson Comprehensive Cancer Center at 2 sites in United States.
Trial summary
RATIONALE: Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody ABX-EGF in treating patients who have either renal (kidney), prostate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Esophageal Cancer, Kidney Cancer
- What is being tested?
- panitumumab
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Apr 2000to Jul 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following:
- Renal cell cancer (RCC)
- Prior nephrectomy required
- Prostate cancer
- Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy)
- Failed prior hormonal therapy (e.g., antiandrogen, luteinizing hormone-releasing hormone inhibitor, or orchiectomy)
- Pancreatic cancer
- Failed at least 1 prior standard therapy regimen for unresectable metastatic disease
- Non-small cell lung cancer
- Failed at least 1 prior standard therapy regimen for unresectable metastatic disease
- Colorectal cancer
- Received 1 or more prior chemotherapy regimen(s) for advanced metastatic disease
- Esophageal cancer
- Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy)
- Gastroesophageal junction cancer
- Evaluable disease
- Epidermal growth factor receptor overexpression
- Tumor tissue must yield the sum of 1+, 2+, or 3+ staining in at least 10% of evaluated tumor cells
- No uncontrolled brain metastases
- No evidence of disease progression or regression after a 30-day washout period
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100% OR
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- AST/ALT no greater than 2 times upper limit of normal (ULN) (3 times ULN for liver metastases)
- Alkaline phosphatase no greater than 2 times ULN (3 times ULN for liver metastases)
Renal:
- Creatinine less than 2.2 mg/dL
- NCI renal toxicity no greater than grade 2
- No hypercalcemia (antihypercalcemic therapy allowed)
Cardiovascular:
- Ejection fraction at least 45% by MUGA
- No abnormal ECG or MUGA
- No myocardial infarction within the past year
Pulmonary:
- No abnormal chest x-ray
- FEV_1 greater than 50% of predicted
Other:
- No known allergy to ingredients of study drug
- No known allergy to Staphylococcus aureus Protein A
- HIV negative
- No chronic medical or psychiatric condition that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 30 days since prior biologic therapy (e.g., antibodies, cytokines, or co-stimulatory pathway inhibitors)
- No other concurrent biologic therapy
Chemotherapy:
- See Disease Characteristics
- At least 6 weeks since prior chemotherapy and recovered
- No prior chemotherapy for RCC
- No prior anthracyclines
- No concurrent chemotherapy
Endocrine therapy:
- See Disease Characteristics
- Concurrent steroids allowed
- Concurrent hormonal therapy allowed
Radiotherapy:
- See Disease Characteristics
- No prior mediastinal radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- Recovered from any recent prior surgery
Other:
- At least 30 days since prior investigational drug or device
- At least 30 days since prior systemic therapy
- No other concurrent investigational drugs
- No other concurrent systemic agents or cancer therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1738
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: An Open Label, Multiple Dose, Dose-Rising Clinical Trial of the Safety of ABX-EGF in Patients With Renal, Prostate, Pancreatic, Non-Small-Cell Lung, Colorectal, or Esophageal Cancer
RATIONALE: Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody ABX-EGF in treating patients who have either renal (kidney), prostate, pancreatic, non-small cell lung, colon, rectal, esophageal, or gastroesophageal junction cancer.
Read the detailed description
OBJECTIVES:
- Determine the safety of monoclonal antibody ABX-EGF in patients with renal, prostate, pancreatic, non-small cell lung, colorectal, esophageal, or gastroesophageal junction cancer.
- Determine the pharmacokinetics and the dose-response relationship of this drug in this patient population.
- Evaluate the clinical effect of this drug in this patient population.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly on weeks 0-3* (enrollment for the weekly dosing schedule completed as of 4/21/03 [with the exception of patients undergoing full pharmacokinetic analyses, described below]) OR once every 2 weeks on weeks 0, 2, 4, and 6* OR once every 3 weeks on weeks 0, 3, 6, and 9*. Patients undergoing full pharmacokinetic analyses receive a loading dose on week 0 and the subsequent 3 doses on weeks 3-5.
NOTE: *All patients receive a total of 4 doses.
Cohorts of 2-8 patients receive escalating doses of monoclonal antibody ABX-EGF until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 or 3 patients experience dose-limiting toxicity.
Patients are followed every 2 weeks for 5 weeks.
PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within approximately 14 months.
- Conditions
- Colorectal Cancer, Esophageal Cancer, Kidney Cancer, Lung Cancer, Pancreatic Cancer, Prostate Cancer
- Being tested
- panitumumab
- Keywords
- recurrent renal cell cancer, recurrent prostate cancer, recurrent colon cancer, recurrent rectal cancer, recurrent non-small cell lung cancer, recurrent pancreatic cancer, recurrent esophageal cancer
- Medical subject headings
- Colorectal Neoplasms, Esophageal Neoplasms, Kidney Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms, Carcinoma, Renal Cell, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
panitumumabBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 2000
- Primary completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Arie Belldegrun, MD, FACS, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004879
- Sponsor's protocol ID
- CDR0000067539
- Other IDs
- UCLA-9906078, ABX-EG-9901, UCLA-9906078-04B, NCI-G00-1673
- Status last verified
- Jan 2013
- First submitted
- 7 Mar 2000
- Last updated
- 8 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multiple Dose, Dose-Rising Clinical Trial of the Safety of ABX-EGF in Patients With Renal, Prostate, Pancreatic, Non-Small-Cell Lung, Colorectal, or Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00004879
- Acronym / sponsor ID
- CDR0000067539
- Conditions
- Colorectal Cancer, Esophageal Cancer, Kidney Cancer, Lung Cancer, Pancreatic Cancer, Prostate Cancer
- Keywords
- recurrent renal cell cancer, recurrent prostate cancer, recurrent colon cancer, recurrent rectal cancer, recurrent non-small cell lung cancer, recurrent pancreatic cancer, recurrent esophageal cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2000
- Primary completion
- Jul 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody ABX-EGF in treating patients who have either renal (kidney), prostate, pancreatic, non-small cell lung, colon, rectal, esophageal, or gastroesophageal junction cancer.
Detailed description
OBJECTIVES:
- Determine the safety of monoclonal antibody ABX-EGF in patients with renal, prostate, pancreatic, non-small cell lung, colorectal, esophageal, or gastroesophageal junction cancer.
- Determine the pharmacokinetics and the dose-response relationship of this drug in this patient population.
- Evaluate the clinical effect of this drug in this patient population.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly on weeks 0-3* (enrollment for the weekly dosing schedule completed as of 4/21/03 [with the exception of patients undergoing full pharmacokinetic analyses, described below]) OR once every 2 weeks on weeks 0, 2, 4, and 6* OR once every 3 weeks on weeks 0, 3, 6, and 9*. Patients undergoing full pharmacokinetic analyses receive a loading dose on week 0 and the subsequent 3 doses on weeks 3-5.
NOTE: *All patients receive a total of 4 doses.
Cohorts of 2-8 patients receive escalating doses of monoclonal antibody ABX-EGF until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 or 3 patients experience dose-limiting toxicity.
Patients are followed every 2 weeks for 5 weeks.
PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within approximately 14 months.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
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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.
Arie Belldegrun, MD, FACS principal investigator
Jonsson Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing panitumumab in people with Colorectal Cancer and Esophageal Cancer, run by Jonsson Comprehensive Cancer Center 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?
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 8 Jan 2013. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 8 Jan 2013; AzTrials last refreshed its copy on 8 Nov 2026.