Trials / Withdrawn
WithdrawnNCT01941173
Short-Infusion Ziv-aflibercept in Treating Patients With Metastatic Colorectal Cancer Receiving Combination Chemotherapy
A Prospective Study of Short Infusion of Ziv-Aflibercept in Combination With FOLFIRI in Patients With Metastatic Colorectal Cancer
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- City of Hope Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This pilot clinical trial studies short-infusion ziv-aflibercept in treating patients with metastatic colorectal cancer receiving combination chemotherapy. Ziv-aflibercept may stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving the drug over a shorter infusion time may result in improved efficiency and patient satisfaction.
Detailed description
PRIMARY OBJECTIVES: I. To determine the feasibility of a shorter infusion of 30 minutes and 15 minutes of standard dose ziv-aflibercept when combined with FOLFIRI (folinic acid \[leucovorin calcium\], fluorouracil, and irinotecan \[irinotecan hydrochloride\]) in patients with metastatic colorectal cancer. SECONDARY OBJECTIVES: I. Describe the institutional safety experience with this combination using Common Terminology Criteria for Adverse Events (CTCAE) version 4 for toxicity grading. OUTLINE: Patients receive ziv-aflibercept intravenously (IV) over 15-30 minutes followed by FOLFIFRI chemotherapy comprising leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV over 46 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Conditions
- Recurrent Colon Cancer
- Recurrent Rectal Cancer
- Stage IVA Colon Cancer
- Stage IVA Rectal Cancer
- Stage IVB Colon Cancer
- Stage IVB Rectal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ziv-aflibercept | Given IV |
| DRUG | leucovorin calcium | Given IV |
| DRUG | irinotecan hydrochloride | Given IV |
| DRUG | fluorouracil | Given IV |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2014-07-01
- First posted
- 2013-09-13
- Last updated
- 2014-07-21
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01941173. Inclusion in this directory is not an endorsement.