Clinical trial NCT00801294: A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer
Official title: A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-12-03
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to explore the overall objective best response rate and the rate of non-progression at 16 weeks of sequential, alternating weekly administration of BIBF 1120 and BIBW 2992 in patients with metastatic CRC based on the RECIST criteria.


Eligibility criteria: Inclusion Criteria:

1. Age over 18 years.
2. Signed informed consent.
3. Histologically proven colorectal adenocarcinoma
4. History or presence of metastatic colorectal cancer (stage IV)
5. Measurable (\>1 cm) or evaluable tumour deposit (according to RECIST criteria)
6. Documented progression or unacceptable toxicity on the last therapy
7. Progression on oxaliplatin-based chemotherapy or unacceptable residual neurotoxicity on oxaliplatin
8. Progression on irinotecan-based chemotherapy or unacceptable toxicity on irinotecan
9. If patients have been previously exposed to Cetuximab or other EGFR inhibitor, they must have shown progression or unacceptable toxicity
10. If patients have been previously exposed to Bevacizumab or other VEGF inhibitor, they must have shown progression or unacceptable toxicity
11. Life expectancy of at least 12 weeks.
12. WHO (ECOG) performance status \<= 2, \<= 1 if age \> 75 years.
13. Adequate hepatic function
14. Adequate renal function

Exclusion Criteria:

1. Prior treatment with small molecule EGFR, HER2 or VEGFR tyrosine kinase inhibitors
2. Treatment with standard chemotherapy or cetuximab within the last 14 days
3. Treatment with bevacizumab within the last 28 days
4. History of other malignancies in the last 5 years, which could affect compliance with the protocol or interpretation of results. Patients with adequately treated basal or squamous cell skin cancer are generally eligible.
5. Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality
6. Significant cardiovascular diseases
7. History of haemorrhagic or thrombotic event in the past 12 months. Known inherited predisposition to bleeds or to thrombosis.
8. Patient with history or clinical or radiological evidence of CNS disease or brain metastases.
9. Pregnancy or breast-feeding

Primary outcomes:
measure: The RECIST criterion will be used to assess: objective response rate (PR + CR), and disease progression within the first 16 weeks
timeFrame: every 4 weeks
measure: PFS
timeFrame: 16 weeks
Secondary outcomes:
measure: Progression-free survival (based on the RECIST criteria)
timeFrame: 66 Weeks
measure: Overall survival
timeFrame: 66 Weeks
measure: The incidence and intensity of Adverse Events with grading of Adverse Events according to the US NCI Common Terminology Criteria for Adverse Events (CTCAE version 3.0)
timeFrame: 66 Weeks
measure: Changes in safety laboratory parameters
timeFrame: 66 Weeks
measure: Effectiveness of dose reduction guidelines in managing adverse events
timeFrame: 66 Weeks
Other outcomes:
Locations:
city: Lyon
country: France
facility: 1239.2.3305A clinique Saint Jean
city: Lyon
country: France
facility: 1239.2.3305B Cabinet Médical
city: Paris Cedex 12
country: France
facility: 1239.2.3301A Hôpital Saint Antoine
city: Paris Cedex 12
country: France
facility: 1239.2.3301B Hôpital Saint Antoine
city: Paris Cedex 12
country: France
facility: 1239.2.3301C Hôpital Saint Antoine
city: Paris Cedex 12
country: France
facility: 1239.2.3301D Hôpital Saint Antoine
city: Paris Cedex 12
country: France
facility: 1239.2.3301E Hôpital Saint Antoine
city: Paris Cedex 12
country: France
facility: 1239.2.3301F Hôpital Saint Antoine
city: Paris Cedex 12
country: France
facility: 1239.2.3301G Hôpital Saint Antoine
city: Paris Cedex 12
country: France
facility: 1239.2.3301H Hôpital Saint Antoine
city: Paris Cedex 12
country: France
facility: 1239.2.3301I Hôpital Saint Antoine
city: Paris Cedex 12
country: France
facility: 1239.2.3301J Hôpital Saint Antoine
city: Paris Cedex 12
country: France
facility: 1239.2.3301K Hôpital Saint Antoine
city: Paris Cedex 20
country: France
facility: 1239.2.3302A Hôpital Tenon
city: Paris Cedex 20
country: France
facility: 1239.2.3302B Hôpital Tenon
city: Reims Cedex
country: France
facility: 1239.2.3304A Hôpital Robert Debré
city: Reims Cedex
country: France
facility: 1239.2.3304B Hôpital Robert Debré
city: Reims Cedex
country: France
facility: 1239.2.3304C Hôpital Robert Debré
city: Villejuif Cedex
country: France
facility: 1239.2.3303A Institut Gustave Roussy
city: Villejuif Cedex
country: France
facility: 1239.2.3303B Institut Gustave Roussy
city: Villejuif Cedex
country: France
facility: 1239.2.3303C Institut Gustave Roussy
city: Villejuif Cedex
country: France
facility: 1239.2.3303D Institut Gustave Roussy
city: Villejuif Cedex
country: France
facility: 1239.2.3303E Institut Gustave Roussy
city: Villejuif Cedex
country: France
facility: 1239.2.3303F Institut Gustave Roussy
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: