FOLFOX and Bevacizumab With or Without Irinotecan in First-line Treatment for Metastatic Colorectal Cancer. A Randomized Phase II Study
18 Years
N/A
Both
Metastatic Colorectal Cancer
Trial Information
FOLFOX and Bevacizumab With or Without Irinotecan in First-line Treatment for Metastatic Colorectal Cancer. A Randomized Phase II Study
5-Fluorouracil and oxaliplatin (FOLFOX-Regimen) in combination with bevacizumab is regarded
as standard first-line treatment in metastatic colorectal cancer [Saltz et al., 2008].
Current studies established the role of the FOLFOXIRI regimen [Souglakos et al., 2006,
Falcone et al., 2007]. A further intensification of the therapy seems feasible yielding
response rates up to 84% and a disease control rate up to 100% [Falcone, 2008, Santomaggio,
2009, Masi, 2010]. This trial evaluates the activity of an intensified first-line therapy
for metastatic colorectal cancer compared to standard treatment.
Inclusion Criteria:
1. Patients with histologically confirmed diagnosis of stage IV (UICC) colorectal cancer
(primary tumor may be present)
2. Patients with at least one measurable lesion, with size > 1 cm (RECIST v1.1)
3. ECOG Performance status ≤ 2 (ECOG 2, only if tumor related)
4. Patients, who are able to tolerate intensive first lien treatment as judged by the
investigator
5. Life expectancy > 3 months
6. Age ≥ 18 years
7. Haematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 100 x109/L, hemoglobin
- 9 g/dl or 5.59 mmol/l
8. Patients not receiving therapeutic anticoagulation must have an INR < 1.5 ULN and
aPTT < 1.5 ULN within 7 days prior to registration. The use of full dose
anticoagulants is allowed as long as the INR or aPTT is within therapeutic limits
(according to the medical standard in the institution) and the patient has been on a
stable dose for anticoagulants for at least two weeks at the time of registration.
9. Adequate liver function as measured by serum transaminases (AST & ALT) ≤ 2.5 x ULN
(in case of liver metastases < 5 x ULN) and total bilirubin ≤ 1.5 x ULN
10. Adequate renal function: Serum creatinine ≤ 1.5 x ULN
11. Signed, written informed consent
Exclusion Criteria:
1. Patients with histologically confirmed diagnosis of stage IV (UICC) colorectal cancer
(primary tumor may be present)
2. Patients with at least one measurable lesion, with size > 1 cm (RECIST v1.1)
3. ECOG Performance status ≤ 2 (ECOG 2, only if tumor related)
4. Patients, who are able to tolerate intensive first lien treatment as judged by the
investigator
5. Life expectancy > 3 months
6. Age ≥ 18 years
7. Haematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 100 x109/L, hemoglobin
- 9 g/dl or 5.59 mmol/l
8. Patients not receiving therapeutic anticoagulation must have an INR < 1.5 ULN and
aPTT < 1.5 ULN within 7 days prior to registration. The use of full dose
anticoagulants is allowed as long as the INR or aPTT is within therapeutic limits
(according to the medical standard in the institution) and the patient has been on a
stable dose for anticoagulants for at least two weeks at the time of registration.
9. Adequate liver function as measured by serum transaminases (AST & ALT) ≤ 2.5 x ULN
(in case of liver metastases < 5 x ULN) and total bilirubin ≤ 1.5 x ULN
10. Adequate renal function: Serum creatinine ≤ 1.5 x ULN
11. Signed, written informed consent
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
progression free survival rate
Outcome Time Frame:
9 months after first study drug administration
Safety Issue:
No
Principal Investigator
Hans-Joachim Schmoll, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Universitätsklinikum Halle
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
AIO-0209
NCT ID:
NCT01321957
Start Date:
May 2011
Completion Date:
January 2016
Related Keywords:
- Metastatic Colorectal Cancer
- Colorectal Neoplasms
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