Clinical trial · Interventional
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
NCT00027729CI-TRIAL-00010615completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| etaracizumab | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.