ZD6474, Cetuximab, and Irinotecan in Patients With Metastatic Colorectal Cancer
Completed · Phase 1
Conditions studied: Colorectal Cancer
In brief
This research study will test the safety of the investigational drug, ZD6474, in combination with 2 other drugs that are standard in the treatment of colon and rectal cancer (cetuximab and irinotecan). ZD6474 blocks the action of two substances in the body: vascular endothelial growth factor receptor (VEGFR) and epidermal growth factor receptor (EGFR). VEGFR stimulates the formation of new blood vessels. When cancer cells produce VEGFR, new blood vessels are made that provide blood to the cancer cells. The blood carries nutrients and oxygen, allowing the cancer cells to live and grow. EGFR controls how quickly cells grow and multiply. Both of these substances are found on normal cells, but they are found in much higher levels on cancer cells.
Key facts
- Study ID
- NCT00436072
- Run by
- Dana-Farber Cancer Institute
- People needed
- 46
- Starts
- 2007-02-01
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2012-10-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically documented locally advanced or metastatic colorectal cancer
- 1-2 prior therapies for metastatic colorectal cancer. Prior adjuvant therapy not included in the number of priors unless recurrence within 12 months of last dose of therapy and then the adjuvant therapy will be counted.
- Tumor is K-ras wildtype by method of choice at respective institution (testing codons 12 and 13)
- Measurable disease according to the RECIST criteria
- 18 years of age or older
- ECOG Performance Status of 0-2
- Completed any major surgery 4 weeks from registration and any minor surgery 2 weeks from registration
- Adequate bone marrow function
- Adequate renal function
- Adequate hepatic function
- Normal range of serum calcium and magnesium
- Agree to use an effective form of contraception during the study and 90 days following the last dose of medication
- Negative urine or serum pregnancy test
You may not qualify if…
- History of prior malignancy within the past 3 years except curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or treated localized prostate cancer
- Prior therapy with gefitinib, erlotinib, cetuximab, ABX-EGF or other specific EGFR inhibitor
- Known hypersensitivity to any components of each drug
- Pregnant or lactating women
- Any other medical condition, including mental illness or substance abuse, deemed by the clinician to be likely to interfere
- Potassium < 4.0 mEg/L despite supplementation
- Evidence of severe or uncontrolled systemic disease or any concurrent illness that, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol
- Clinically significant cardiac event such as myocardial infarction: NYHA classification of heart disease greater than or equal to 2 that, in the opinion of the investigator, increases the risk of ventricular arrhythmia within 3 months before entry; or presence of cardiac disease
- History of arrythmia which is symptomatic or requires treatment or asymptomatic sustained ventricular tachycardia
- Previous history of QTc prolongation as a result from other medication that required discontinuation of that medication
- Congenital long QT syndrome, or 1st degree relative with unexplained sudden death under 40 years of age
- Presence of left bundle branch block
- QTc with Bazett's correction that is unmeasurable , or greater then 480msec on screening ECG
- Any concomitant medication that may cause QTc prolongation, induce Torsades de Pointes or induce CYP3A4 function
- Hypertension not controlled by medical therapy
- Patients lacking physical integrity of the upper gastrointestinal tract or who have malabsorption syndrome
- Currently active diarrhea that may affect patient's ability to absorb ZD6474 or tolerate potential diarrhea from study drugs
- For patients entering dose levels 4-6, prior history of irinotecan toxicity requiring a dose reduction lower than the dose of irinotecan that the patient will be receiving on this study
- Receipt of any investigational agents within 30 days prior to commencing study treatment
- Last dose of prior chemotherapy or radiation therapy discontinued less thn 4 weeks before the start of study therapy
- Incompletely healed surgical incisions, at the discretion of the investigator
- Any unresolved toxicity greater than CTC grade 1 from previous anti-cancer therapy
Where it is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.