Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer

NCT00027729 | Completed Phase 1

• 4 other identifiers: 01-078CDR0000069061MEDIMMUNE-MI-CP068NCI-G01-2032
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Colorectal Cancer

Keywords

recurrent colon cancer; recurrent rectal cancer

Interventions

etaracizumab BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

etaracizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Leonard B. Saltz, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2001
• First Posted: January 27, 2003
• Study Start: June 1, 2001
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

US (1)