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A Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Irinotecan/5-fluorouracil/Isovorin (FOLFIRI) Administered Every 2 Weeks in Patients With Metastatic Colorectal Cancer


Phase 1
20 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms, Neoplasm Metastasis

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Trial Information

A Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Irinotecan/5-fluorouracil/Isovorin (FOLFIRI) Administered Every 2 Weeks in Patients With Metastatic Colorectal Cancer


Inclusion Criteria:



- Patients with histologically or cytologically proven malignant tumor of the colon or
rectum which is metastatic and inoperable.

- Patients must have received at least one prior line of treatment with any standard of
care, who have failed the treatment, or who have not been eligible for standard of
care for safety reasons.

Exclusion Criteria:

- Treatment with chemotherapy, hormone therapy, radiotherapy, surgery, blood products,
or any investigational agent within 28 days.

- ECOG Performance Status>1

- Anticipated need for a major surgical procedure or radiation therapy during the
study.

- Uncontrolled malignant ascites.

- History of brain metastases, spinal cord compression, or carcinomatous meningitis or
new evidence of brain or leptomeningeal disease on screening CT or MRI scan.

- Pregnant or breast-feeding women.

- Uncontrolled hypertension

- Patients who have previously been treated with aflibercept

- History of abdominal fistula, GI perforation, or intra-abdominal abscess within the
past 28 days.

- History of hypersensitivity to any recombinant proteins, irinotecan, fluoropyrimidine
or isovorin.

- Known dihydropyrimidine dehydrogenase deficiency.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicity (DLT) combination with FOLFIRI

Outcome Time Frame:

During the first 2 cycles (4 weeks) of study treatment

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

TCD10794

NCT ID:

NCT00921661

Start Date:

June 2009

Completion Date:

June 2012

Related Keywords:

  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • oxaliplatin
  • 5-FU
  • Folinic Acid
  • Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis

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