Phase II Study of Zaltrap and Chemotherapy for Advanced Resectable Colorectal Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT02046538
Phase
PHASE2
Status
Withdrawn

Conditions

  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Leucovorin — DRUG
    400 mg/m2 IV over two hours (or administered concurrently with oxaliplatin or irinotecan, depending on the assigned regimen)
  • Oxaliplatin — DRUG
    85 mg/m2 IV over two hours
  • 5-FU — DRUG
    400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours
  • Irinotecan — DRUG
    180 mg/m2 IV over 90 minutes

Study Details

The purpose of this study is to establish the safety of Zaltrap in patients who undergo pre-operative chemotherapy with Zaltrap. The investigators hypothesize that Zaltrap my impact colorectal cancer growth and metastasis.

Key Dates

Start date
Feb 28, 2014
Status verified
Jan 2017
Primary completion
Feb 29, 2016
Completion
Feb 28, 2018

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Postoperative Chemo WITH Zaltrap
    Subjects will receive 3 months of chemotherapy consisting of either FOLFOX (oxaliplatin, leucovorin, 5-FU) or FOLFIRI (Irinotecan, leucovorin, 5-FU) in the case of liver limited CRC, or FOLFOX (in the case of rectal cancer). Zaltrap will be administered with chemotherapy every 2 weeks for the first 5 out of 6 planned treatment cycles. After a standard 3-4 week recovery period (i.e. 5-6 weeks from the last Zaltrap dose), patients will undergo standard resection. At the time of resection, the tumor will be collected for biomarker discovery. Following resection, patients will receive chemotherapy with zaltrap for 3 additional months. Patients may continue zaltrap (without chemotherapy) until disease recurrence or up to an additional 15 months.
  • Active Comparator: Postoperative chemo WITHOUT zaltrap
    Subjects will receive 3 months of chemotherapy consisting of either FOLFOX (oxaliplatin, leucovorin, 5-FU) or FOLFIRI (Irinotecan, leucovorin, 5-FU) in the case of liver limited CRC, or FOLFOX (in the case of rectal cancer). Zaltrap will be administered with chemotherapy every 2 weeks for the first 5 out of 6 planned treatment cycles. After a standard 3-4 week recovery period (i.e. 5-6 weeks from the last Zaltrap dose), patients will undergo standard resection. At the time of resection, the tumor will be collected for biomarker discovery. Following resection, patients will receive chemotherapy (without zaltrap) for 3 additional months.

Primary Outcome Measure

Number of adverse events experienced [ Time Frame: Approximately 24 months per patient ]

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medical CollegeNew YorkNew York10065-

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By research site
Weill Cornell Medical College· New York, NY

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