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NGR006: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Colorectal Cancer (CRC), Previously Treated With Fluoropyrimidine, Oxaliplatin and Irinotecan Based Regimens


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Colorectal Cancer (CRC)

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Trial Information

NGR006: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Colorectal Cancer (CRC), Previously Treated With Fluoropyrimidine, Oxaliplatin and Irinotecan Based Regimens


This is a phase II, open-label, non-randomized study that will be conducted in patients
affected by advanced or metastatic colorectal cancer (CRC), previously treated with
fluoropyrimidine, oxaliplatin and irinotecan based regimens, that will be conducted using
Simon's two-stage design method.


Inclusion Criteria:



- Patients >18 years affected by advanced or metastatic colorectal cancer (CRC),
previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens,
but not more than three lines of therapy. Adjuvant chemotherapy following definitive
management of the primary lesion in the colon or rectum is allowed and will not be
counted as a line of therapy

- ECOG Performance status 0 - 1

- Patients in progression disease at study entry, CT documented

- Adequate baseline bone marrow, hepatic and renal function, defined as follows:

- Neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/L

- Bilirubin < 1.5 x ULN

- AST and/or ALT < 2.5 x ULN in absence of liver metastases

- AST and/or ALT < 5 x ULN in presence of liver metastases

- Serum creatinine < 1.5 x ULN

- Absence of any conditions in which hypervolemia and its consequences (e.g.
increased stroke volume, elevated blood pressure) or hemodilution could
represent a risk for the patient (reference appendix "Technical data sheet human
albumin")

- Normal cardiac function and absence of uncontrolled hypertension

- Patients must give written informed consent to participate in the study

Exclusion Criteria:

- More than three lines of chemotherapy (except biological agents)

- Concurrent anticancer therapy

- Patients may not receive any other investigational agents while on study

- Clinical signs of CNS involvement

- Patients with active or uncontrolled systemic disease/infections or with serious
illness or medical conditions, which is incompatible with the protocol

- Known hypersensitivity/allergic reaction to human albumin preparations or to any of
the excipients

- Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol

- Pregnancy or lactation. Patients - both males and females - with reproductive
potential (i.e.menopausal for less than 1-year and not surgically sterilized) must
practice effective contraceptive measures throughout the study. Women of childbearing
potential must provide a negative pregnancy test (serum or urine) within 14 days
prior to registration

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Antitumour activity defined as Progression Free Survival (PFS)

Outcome Time Frame:

during the study

Safety Issue:

No

Principal Investigator

Federico Caligaris Cappio, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fondazione San Raffaele del Monte Tabor

Authority:

Italy: Ethics Committee

Study ID:

NGR006

NCT ID:

NCT00483080

Start Date:

December 2006

Completion Date:

June 2013

Related Keywords:

  • Colorectal Cancer (CRC)
  • NGR-hTNF
  • CRC
  • Colorectal Neoplasms

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