Short-Infusion Ziv-aflibercept in Treating Patients With Metastatic Colorectal Cancer Receiving Combination Chemotherapy

Conditions

• Recurrent Colon Cancer
• Recurrent Rectal Cancer
• Stage IVA Colon Cancer
• Stage IVA Rectal Cancer
• Stage IVB Colon Cancer
• Stage IVB Rectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ziv-aflibercept — BIOLOGICAL
  Given IV
• leucovorin calcium — DRUG
  Given IV
• irinotecan hydrochloride — DRUG
  Given IV
• fluorouracil — DRUG
  Given IV

Study Details

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.

Key Dates

Start date

Jan 31, 2014

Status verified

Jul 2014

Primary completion

Jul 31, 2014

Study Design

Enrollment

0 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (ziv-aflibercept, FOLFIRI)
  Patients receive ziv-aflibercept 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.

Primary Outcome Measure

Feasibility of a shorter infusion time, determined by rate of greater or equal to grade 2 hypersensitivity reactions as graded according to CTCAE version 4.0 [ Time Frame: Up to 30 days after last study treatment ]

Locations (3)

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