Health Condition 1: C189- Malignant neoplasm of colon, unspecified
Conditions
Interventions
Intervention1: Bevacizumab (Hetero): Bevacizumab is given at the dose of 7.5mg/kg, every 3 weeks for up to 08 cycles along with standard chemotherapy.
Bevacizumab is given at the dose of 5mg/kg, every
Sponsors
Hetero Drugs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically pre-confirmed metastatic colorectal carcinoma, and not suitable for radical surgery, or radiotherapy at the inclusion time 2. No known brain metastases 3.Performance status - ECOG 0 to 2 4. Life expectancy >= 6 months 5. Major surgery, open surgical biopsy or significant traumatic injury at least 4 weeks before randomization. If post-operative, recovered from the effects of surgery 6. No plan to administer radiation therapy or perform surgery for target lesions during study treatment. (Palliative surgeries or radiation therapy for non-target lesions allowed). 7. INR 8. Adequate liver function: Serum bilirubin 9. Adequate bone-marrow function 10. Ability to comply with study and follow-up procedures and provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Drug allergy, hypersensitivity or intolerance: Known or suspected allergy or hypersensitivity to any component of Bevacizumab 2. Any anticancer treatment (chemotherapy, hormonal treatment, radiation treatment, surgery, immunotherapy, biologic therapy or tumor embolization) within 4 weeks before randomization3. Presence of a serious, non-healing wound, ulcer, or bone fracture 3. Chronic, actual or recent use (10 days prior to first drug administration) of acetylsalicylic acid (aspirin) >325 mg/day or clopidogrel (75 mg/day) or other treatments that can cause gastrointestinal ulcer (low-dose aspirin is permitted 4. History of stroke or transient ischemic attack within 6 months prior to study enrolment 5. History or clinical evidence of uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg on repeated measurement) despite optimal medical management 6. Cardiac arrhythmia 7. Any medical, psychological, or social condition that may interfere with the subjects participation in the study or evaluation of the study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate as per RECIST 1.1 criteriaTimepoint: At baseline and end of treatment cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity- Anti-Bevacizumab antibodies Pharmacokinetic parameters (e.g., Cmax, Tmax & AUC etc.) Exploratory parameters- Estimation of VEGF levels Quality of life: Comparison of Quality of Life (QoL) scores (FACT-C & Treatment Outcome Index) Safety: Adverse events by monitoring of significant clinical signs, symptoms & laboratory abnormalities during treatment. Timepoint: Immunogenicity- Anti-Bevacizumab antibodies from baseline to end of treatment cycles Pharmacokinetic parameters will be calculated at end of first treatment cycle Exploratory parameters- Estimation of VEGF levels from baseline to the end of treatment cycles Quality of life: Comparison of Quality of Life (QoL) scores from baseline to EOT | — |
Countries
India
Contacts
Public ContactDr Rudolph Almeida
Hetero Drugs Ltd
Outcome results
None listed