- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00027729
Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
Phase I/II Study of MEDI-522, A Humanized Monoclonal Antibody Directed Against the Human Alpha V Beta 3 Integrin, in Patients With Irinotecan-Refractory Advanced Colorectal Cancer
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced colorectal cancer that has not responded to irinotecan.
Study Overview
Detailed Description
OBJECTIVES:
- Determine the recommended phase II dose of monoclonal antibody anti-anb3 integrin in patients with irinotecan-refractory advanced colorectal cancer.
- Determine the safety and tolerance of this drug in these patients.
- Determine any antitumor activity of this drug in these patients.
- Determine the objective response rate, response duration, and time to progression in patients treated with this drug.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive monoclonal antibody anti-anb3 integrin IV over 30 minutes once weekly on weeks 1-52 in the absence of disease progression or unacceptable toxicity. Patients with responding disease may continue therapy.
Cohort of 4-6 patients receive escalating doses of monoclonal antibody anti-anb3 integrin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 or 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose in the phase II portion of the study.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 4-24 patients will be accrued for phase I of this study and a total of 40 patients will be accrued for phase II of this study.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically confirmed advanced colorectal cancer
- Disease progression while receiving an irinotecan-containing regimen for metastatic colorectal cancer OR
- Disease recurrence within 6 months after completing an irinotecan-containing regimen in the adjuvant setting
At least 1 measurable lesion (for phase II only)
- At least 20 mm by x-ray, CT scan, MRI, or photograph
- Recurrent disease after surgery or radiotherapy is considered measurable if it has been at least 4 weeks since treatment and measurable disease is outside the port of prior radiotherapy or there is evidence of disease progression within the port of prior radiotherapy
The following are not considered measurable:
- Pleural effusion
- Ascites
- Osteoblastic lesion or evidence of disease on bone scan alone
- Progressive irradiated lesions alone
- Bone marrow involvement
- Brain metastases
- Malignant hepatomegaly by physical exam alone
- Chemical markers (e.g., carcinoembryonic antigen)
- No known brain metastases or primary brain tumors
- No symptomatic pleural effusion or ascites requiring paracentesis
- No clinical evidence of bowel obstruction
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin greater than 10.0 g/dL
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- AST/ALT no greater than 5 times upper limit of normal (ULN)
- PT/PTT less than ULN OR
- INR less than 1.12
- No hepatitis virus infection
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance greater than 50 mL/min
Cardiovascular:
- No prior myocardial infarction
- No angina
- No uncontrolled hypertension (systolic blood pressure greater than 150 mm Hg)
- No prior cerebrovascular accident or transient ischemic attack
Pulmonary:
- No respiratory insufficiency requiring oxygen treatment
- No lymphangitic involvement of lungs
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for 30 days before, during, and for 30 days after study
- Thyroxine and thyroid-stimulating hormone normal
- No hematemesis, melena, hematochezia, or gross hematuria
- No prior significant adverse reaction to a humanized monoclonal antibody
- No known HIV infection
- No active infection requiring systemic anti-infective therapy
- No other medical or psychological condition or behavior, including substance dependence or abuse, that would preclude study
- No other malignancy within the past 5 years except basal cell skin cancer or completely excised carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Prior immunotherapy with approved agents allowed
- No prior monoclonal antibody anti-anb3 integrin or its precursor (MEDI-523)
- No other concurrent immunotherapy
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- No concurrent palliative chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
Surgery:
- See Disease Characteristics
- At least 4 weeks since prior surgery and surgical wounds must have healed
Other:
- Recovered from all prior therapy
- At least 4 weeks since prior investigational agents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01-078
- CDR0000069061 (Registry Identifier: PDQ (Physician Data Query))
- MEDIMMUNE-MI-CP068
- NCI-G01-2032
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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