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Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
etaracizumab
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, recurrent rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 7, 2001
Last Updated
June 4, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00027729
Brief Title
Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
recurrent colon cancer, recurrent rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
etaracizumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard B. Saltz, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer

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