Panitumumab and Bortezomib for Patients With Advanced Colorectal Cancer

NCT01504477 | Terminated Phase 1 Results DMC

• 2 other identifiers: 2011-033X05374
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Panitumumab plus bortezomib for colon cancer

Conditions

Colorectal Cancer

Keywords

colorectal cancer; relapsed; refractory; Kras wild type

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose

  The maximum tolerated dose of bortezomib (to be used in combination with panitumumab)

  12 months

• Maximum Tolerated Dose

  The maximum tolerated dose of panitumumab (to be used in combination with bortezomib)

  12 months

Secondary Outcomes (3)

• Percent of Patients With Disease Control

  16 weeks

• Percent of of Patients With a Complete or Partial Response

  16 weeks

• Duration of Disease Control

  2 years

Study Arms (1)

Combination of Panitumumab and Bortezomib

EXPERIMENTAL

IV panitumumab and bortezomib

Drug: Panitumumab and bortezomib

Interventions

Panitumumab and bortezomib DRUG

Panitumumab 6 mg/kg IV over 60 minutes on Day -14 (first cycle only), then Day 1 and 15 of each 28-day cycle. Bortezomib will be administered in escalating doses until the maximum tolerated dose is determined and then at the maximum tolerated dose as an IV bolus injection over 3-5 seconds on Day 1, 8, and 15 of each 28-day cycle.

Also known as: Velcade, Vectibix

Combination of Panitumumab and Bortezomib

Eligibility Criteria

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

You may qualify if:

• Histologically proven colorectal cancer with measurable or evaluable disease
• KRAS wild-type colorectal cancer
• Progression on, or intolerance of, or ineligibility for all standard therapies
• Progression on prior anti-EGFR therapy
• Lesion that is amenable to biopsy
• ECOG performance status 0-2
• LVEF \>/= institutional normal
• Corrected QT interval less then 500 milliseconds by EKG
• Grade 2 or less peripheral neuropathy
• Adequate hepatic, bone marrow, and renal function
• Partial thromboplastin time must be \</= 1.5 x upper limit of institution's normal range and INR \< 1.5. Subjects on anticoagulants will be permitted to enroll as long as the INR is in the acceptable therapeutic range as determined by the investigator.
• Subjects with no brain metastases or a history of previously treated brain metastases who have been treated by surgery or stereotactic radiosurgery at least 4 weeks prior to enrollment and have a baseline MRI that shows no evidence of active intracranial disease and have not had treatment with steroids within 1 week of study enrollment.
• Life expectancy \> 12 weeks
• Subject is capable of understanding and complying with parameters of the protocol and able to sign and date the informed consent form.

You may not qualify if:

• CNS metastases which do not meet the criteria above
• Prior cancer chemotherapy, radiation therapy, or any investigational agent within three weeks before starting therapy
• Active severe infection or known chronic infection with HIV or hepatitis B virus
• Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
• Peripheral neuropathy \>/= Grade 2 at baseline or peripheral neuropathy \>/= Grade 1 with neuropathic pain
• Life-threatening visceral disease or other severe concurrent disease
• Female subject is pregnant or lactating
• Diagnosed or treated for another malignancy within 3 years of enrollment with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy
• Patient has hypersensitivity to bortezomib, boron, or mannitol
• Clinically significant and uncontrolled major medical condition(s)

Sponsors & Collaborators

• Georgetown University: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Recurrence

Interventions

Panitumumab; Bortezomib

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Michael Pishvaian
• Organization: Georgetown University

pishvaim@georgetown.edu

202-444-2223

Study Officials

• Michael Pishvaian, MD PhD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: January 5, 2012
• Study Start: December 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 16, 2020
• Results First Posted: March 16, 2020

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)