Clinical trial NCT00361244: SU011248 in Combination With Irinotecan and Cetuximab as a Second Line Regimen for Stage IV Colorectal Cancer
Official title: A Phase I/II Study of SU011248 (Sutent) in Combination With Irinotecan and Cetuximab as a Second Line Regimen for Patients With Stage IV Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Colorectal Carcinoma
Keywords: Sutent
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Dana-Farber Cancer Institute
First posted: 2006-08-08
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: * Participants will be given a supply of SU011248 capsules to take at home in the morning for two weeks. After taking the capsules for two weeks, there will be a one-week rest period.
* Irinotecan will be administered on days 1 and 8 of every 21-day cycle as an intravenous infusion over 90 minutes. Cetuximab will be administered intravenously on days 1, 8 and 15 of every 21-day cycle. The first treatment of cetuximab is a larger dose. Beginning with the second treatment, the participant will receive a smaller dose of cetuximab.
* Blood work will be repeated at every clinic visit on days 1 and 8. During cycle 1, blood will also be drawn on day 15.
* Tumor assessments will be repeated after 6 weeks, 12 weeks, and every 9 weeks thereafter, and will be assessed by both a CT scan of the abdomen, pelvis, and a chest x-ray. MUGA scans will be repeated every 4 cycles (12 weeks).
* Participants may continue to receive cycles of study treatment as long as their disease does not progress and they do not experience any serious side effects.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: 1 year
measure: To determine the response rate of SU011248 when given in combination with irinotecan and cetuximab in this patient population.
Secondary outcomes:
measure: To evaluate the toxicities of this combination of drugs in this patient population
timeFrame: 1 year
measure: to assess overall survival, progression-free survival, time to progression and duration of response.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Andrew X. Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References: