Status:
UNKNOWN
Maintenance Treatment Versus Observation After Induction in Advanced Colorectal Carcinoma
Lead Sponsor:
Dutch Colorectal Cancer Group
Collaborating Sponsors:
Koningin Wilhelmina Fonds
Sanofi
Conditions:
Colorectal Cancer Metastatic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The optimal duration of systemic treatment in patients with advanced colorectal cancer is unknown. In this study the effects of bevacizumab and low-dose continuous chemotherapy with capecitabine is i...
Detailed Description
Standard 1st-line treatment for patients with advanced colorectal cancer currently consists of chemotherapy plus bevacizumab. With this approach the median overall survival is approximately 20 months,...
Eligibility Criteria
Inclusion
- Before the start of induction therapy:
- Inclusion Criteria:
- Histological proof of colorectal cancer (in case of a single metastasis, histological or cytological proof of this lesion should be obtained);
- Distant metastases (patients with only local recurrence are not eligible);
- Unidimensionally measurable disease (\> 1 cm on spiral CT scan or \> 2 cm on chest X-ray; liver ultrasound is not allowed). Serum CEA may not be used as a parameter for disease evaluation;
- In case of previous radiotherapy, at least one measurable lesion should be located outside the irradiated field.
- Ongoing or planned first line treatment with 6 cycles of Xeloda, Eloxatin, and Avastin.
- Exclusion criteria
- Prior adjuvant treatment for stage II/III colorectal cancer ending within 6 months before the start of induction treatment
- Any prior adjuvant treatment after resection of distant metastases
- Previous systemic treatment for advanced disease
- At randomisation:
- Inclusion criteria:
- WHO performance status 0-1 (Karnofsky PS \> 70%);
- Disease evaluation with proven SD, PR or CR according to RECIST after 6 cycles of MTD chemotherapy performed in week 3-4 of the 6th cycle induction therapy, and randomisation performed in week 3-5 of the 6th cycle (see time table);
- Laboratory values obtained ≤ 2 weeks prior to randomisation: adequate bone marrow function (Hb \> 6.0 mmol/L, absolute neutrophil count \> 1.5 x 109/L, platelets \> 100 x 109/L), renal function (serum creatinine ≤ 1.5x ULN and creatinine clearance, Cockroft formula, \> 30 ml/min), liver function (serum bilirubin ≤ 2 x ULN, serum transaminases ≤ 3 x ULN without presence of liver metastases or ≤ 5x ULN with presence of liver metastases);
- Life expectancy \> 12 weeks;
- Age \>= 18 yrs;
- Negative pregnancy test in women with childbearing potential;
- Expected adequacy of follow-up;
- Institutional Review Board approval;
- Written informed consent Exclusion criteria
- History or clinical signs/symptoms of CNS metastases;
- History of a second malignancy ≤ 5 years with the exception of adequately treated carcinoma of cervix or basal/squamous cell carcinoma of skin;
- Previous intolerance of XelodaR, EloxatinR, and/or AvastinR for which any of these drugs have been permanently discontinued; patients with previous dose reductions or delays are eligible; patients with grade 2 neurotoxicity after the 6th cycle are eligible, and retreatment with EloxatinR after PFS1 should depend on the grade of neurotoxicity at that moment;
- Known dihydropyrimidine dehydrogenase (DPD) deficiency;
- (Planned) radical resection of all metastatic disease;
- Uncontrolled hypertension, i.e. consistently \> 150/100 mmHg;
- Use of more than 3 antihypertensive drugs;
- Significant cardiovascular disease \< 1 yr before randomisation (symptomatic congestive heart failure, myocardial ischemia or infarction, unstable angina pectoris, serious uncontrolled cardiac arrhythmia, arterial thrombosis, cerebrovascular event, pulmonary embolism);
- Any of these significant cardiovascular events during previous fluoropyrimidine therapy;
- Chronic active infection;
- Any other concurrent severe or uncontrolled disease preventing the safe administration of study drugs;
- Any impairment of gastrointestinal function or -disease that may significantly impair the absorption of oral drugs (i.e. uncontrolled nausea, vomiting, diarrhoea (defined as \>CTC grade 2), malabsorption syndrome, bowel obstruction, or inability to swallow tablets);
- Concomitant treatments: concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation; concurrent treatment with any other anti-cancer therapy; full-dose anticoagulation (is allowed if started during induction therapy);
- Continuous use of immunosuppressive agents (except the use of corticosteroids as anti-emetic prophylaxis/treatment).
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
635 Patients enrolled
Trial Details
Trial ID
NCT00442637
Start Date
January 1 2007
End Date
December 1 2013
Last Update
December 12 2013
Active Locations (1)
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1
University Medical Center Nijmegen
Nijmegen, Gelderland, Netherlands