SU011248 in Combination With Irinotecan and Cetuximab as a Second Line Regimen for Stage IV Colorectal Cancer

NCT00361244 | Terminated Phase 1

• 1 other identifier: 05-439
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine the safety of SU011248 and the highest dose of this drug that can be given safely in combination with the chemotherapy drugs irinotecan and cetuximab. Laboratory studies have shown that SU011248 may block the growth of blood vessels in tumors, which may prevent tumors from growing any further. Other studies have demonstrated the possibility that SU011248 may enhance the anti-tumor activity of other chemotherapy drugs such as irinotecan and cetuximab.

Conditions

Colorectal Carcinoma

Keywords

Sutent

Outcome Measures

Primary Outcomes (2)

• To determine the maximum tolerated dose of SU011248 when given in combination with irinotecan and cetuximab in patients with previously treated locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma

  1 year

• To determine the response rate of SU011248 when given in combination with irinotecan and cetuximab in this patient population.

Secondary Outcomes (2)

• To evaluate the toxicities of this combination of drugs in this patient population

  1 year

• to assess overall survival, progression-free survival, time to progression and duration of response.

Interventions

SU011248 DRUG

Given orally in the morning for two weeks followed by a one week rest period (one cycle equals 21 days). Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.

Irinotecan DRUG

Given intravenously on days 1 and 8 of each 21-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.

Cetuximab DRUG

Given intravenously on days 8 and 15 of each 21-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.

Eligibility Criteria

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

You may qualify if:

• Histologic proof of adenocarcinoma of the colon or rectum with evidence of metastatic disease. The site of the primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel
• Patients must have received one (and only one) prior chemotherapy regimen for metastatic disease using 5-FU/LV or Xeloda in combination with oxaliplatin and Avastin.
• \> 4 weeks must have elapsed from the time of major surgery
• \> 2 weeks must have elapsed from the time of minor surgery
• \> 4 weeks must have elapsed from the time of major radiotherapy
• Normal organ and marrow function
• Measurable disease be RECIST criteria
• Older than 18 years of age
• ECOG performance status of 0-1
• Life expectancy \> 12 weeks

You may not qualify if:

• Previous treatment with irinotecan, cetuximab or SU011248
• Any of the following within the 12 months prior to study drug administration: severe/unstable angina; myocardial infarction; symptomatic congestive heart failure; cerebrovascular accident; or transient ischemic attack.
• Known brain metastases or carcinomatous meningitis
• Uncontrolled serious medical or psychiatric illness
• NCI CTCAE grade 3 or greater hemorrhage within 4 weeks of starting study treatment
• Uncontrolled hypertension
• Diagnosis of any secondary malignancies with the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, localized prostate cancer with a normal PSA within the past 3 months, in situ bladder cancer, or in situ cervical cancer
• Pregnant or breastfeeding
• Concurrent treatment on another clinical trial

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Sunitinib; Irinotecan; Cetuximab

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

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Camptothecin; Alkaloids; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Andrew X. Zhu, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Hematology/Oncology

Study Record Dates

• First Submitted: August 4, 2006
• First Posted: August 8, 2006
• Study Start: July 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: August 1, 2010
• Last Updated: February 17, 2017

Record last verified: 2017-02

Locations

US (3)