A Phase 2/3 interventional study of Cediranib and Bevacizumab in Colorectal Cancer, sponsored by AstraZeneca. Completed at 283 sites in 28 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2017-04-14.
Sponsored by AstraZeneca · Phase 2/3, Interventional, and Treatment
The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab) in combination with FOLFOX.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's enrollment of 1,814 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bevacizumab + FOLFOX
Drug: Bevacizumab · Drug: 5-fluorouracil ( in FOLFOX) · Drug: Leucovorin (in FOLFOX) · Drug: Oxaliplatin (in FOLFOX)
Cediranib + FOLFOX
Drug: Cediranib · Drug: 5-fluorouracil ( in FOLFOX) · Drug: Leucovorin (in FOLFOX) · Drug: Oxaliplatin (in FOLFOX)
oral tablet once daily
Also known as: RECENTIN™, AZD2171
intravenous infusion
Also known as: Avastin®
intravenous infusion
Also known as: 5-FU
intravenous infusion
intravenous infusion
Also known as: Eloxatin®
Progression Free Survival
Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
Time frame: Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression
Overall Survival
Number of months from randomisation to the date of death from any cause
Time frame: Randomisation until data cut-off
Objective Response Rate
Objective response rate is Complete Response (CR) + Partial Response (PR) as defined below: CR = Disappearance of all target lesions. PR = At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs.
Time frame: Up until data cut-off
Duration of Response
Duration of Response is calculated as the time from the first recording of CR/PR until the patient progresses, regardless of whether the patient was still taking study medication. Only confirmed responses are included in the calculation. For patients who had not progressed, the end date used in the calculation of duration of response is the data cut-off date of 15th November 2009.
Time frame: Up until data cut-off date of 15/11/2007
Percentage Change in Tumour Size
Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)\*100
Time frame: Baseline to Week 8
Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)
Time to worsening of symptoms, as measured by the FACT colorectal symptom index (FCSI), will be defined as the time when a sustained clinically important deterioration in the total score from the FCSI has been recorded.
Time frame: Baseline through to data cut-off
Enrolled = 1814 though not all patient randomised. Randomised= Intent to treat (ITT): Cediranib 20mg 709, Cediranib 30mg 192 Bevacizumab 713; Safety: Cediranib 20mg 705, Cediranib 30mg 191 Bevacizumab 704
| Milestone | Cediranib 20 mg | Bevacizumab 5 mg/kg | Cediranib 30 mg |
|---|---|---|---|
| Started | 709 | 713 | 192 |
| Completed | 397 | 394 | 60 |
| Not completed | 312 | 319 | 132 |
| Withdrew: Death | 239 | 247 | 105 |
| Withdrew: Withdrawal by subject | 52 | 48 | 22 |
| Withdrew: Lost to follow-up | 16 | 18 | 4 |
| Withdrew: Incorrect enrol/elig crit not fulfilled | 2 | 3 | 0 |
| Withdrew: Longer qtc as visit 1 | 1 | 0 | 0 |
| Withdrew: Toxicity of treatment | 1 | 0 | 0 |
| Withdrew: Did not receive study treatment | 0 | 1 | 1 |
| Withdrew: Physician decision | 0 | 2 | 0 |
| Withdrew: Liver metastases, colon resec. planned | 1 | 0 | 0 |
Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
| Months | Cediranib 20 mg | Bevacizumab 5 mg/kg | Cediranib 30 mg |
|---|---|---|---|
| Progression Free Survival | 9.9 (6.3 to 13.5) | 10.3 (6.5 to 14.1) | — |
Number of months from randomisation to the date of death from any cause
| Months | Cediranib 20 mg | Bevacizumab 5 mg/kg | Cediranib 30 mg |
|---|---|---|---|
| Overall Survival | 22.8 (13.3 to 32.3) | 21.3 (12.2 to 32.8) | — |
Objective response rate is Complete Response (CR) + Partial Response (PR) as defined below: CR = Disappearance of all target lesions. PR = At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs.
| Participants | Cediranib 20 mg | Bevacizumab 5 mg/kg | Cediranib 30 mg |
|---|---|---|---|
| Objective Response Rate | 328 | 337 | — |
Duration of Response is calculated as the time from the first recording of CR/PR until the patient progresses, regardless of whether the patient was still taking study medication. Only confirmed responses are included in the calculation. For patients who had not progressed, the end date used in the calculation of duration of response is the data cut-off date of 15th November 2009.
| Months | Cediranib 20 mg | Bevacizumab 5 mg/kg | Cediranib 30 mg |
|---|---|---|---|
| Duration of Response | 8.6 (6.1 to 12.1) | 9.6 (6.5 to 13.6) | — |
Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)\*100
| Percentage change in tumour size | Cediranib 20 mg | Bevacizumab 5 mg/kg | Cediranib 30 mg |
|---|---|---|---|
| Percentage Change in Tumour Size | -23.2 ± 21.8 | -22.1 ± 19.55 | — |
Time to worsening of symptoms, as measured by the FACT colorectal symptom index (FCSI), will be defined as the time when a sustained clinically important deterioration in the total score from the FCSI has been recorded.
| Days | Cediranib 20 mg | Bevacizumab 5 mg/kg | Cediranib 30 mg |
|---|---|---|---|
| Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI) | 170 (56 to 328) | 245 (112 to 348) | — |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cediranib 20 mg | — | 275/705 (39%) | 684/705 (97%) |
| Cediranib 30 mg | — | 90/191 (47.1%) | 187/191 (97.9%) |
| 1Bevacizumab 5mg/kg | — | 231/704 (32.8%) | 672/704 (95.5%) |
| Event | Cediranib 20 mg | Cediranib 30 mg | 1Bevacizumab 5mg/kg |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 30/705 | 11/191 | 13/704 |
| PyrexiaGeneral disorders | 21/705 | 9/191 | 11/704 |
| FatigueGeneral disorders | 6/705 | 7/191 | 0/704 |
| Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders | 13/705 | 6/191 | 21/704 |
| NeutropeniaBlood and lymphatic system disorders | 8/705 | 5/191 | 11/704 |
| DehydrationMetabolism and nutrition disorders | 6/705 | 5/191 | 8/704 |
| HypertensionVascular disorders | 9/705 | 4/191 | 2/704 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 11/705 | 1/191 | 13/704 |
| Intestinal ObstructionGastrointestinal disorders | 9/705 | 2/191 | 12/704 |
| VomitingGastrointestinal disorders | 11/705 | 3/191 | 12/704 |
| Event | Cediranib 20 mg | Cediranib 30 mg | 1Bevacizumab 5mg/kg |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 486/705 | 147/191 | 354/704 |
| NauseaGastrointestinal disorders | 355/705 | 100/191 | 349/704 |
| HypertensionVascular disorders | 292/705 | 92/191 | 183/704 |
| FatigueGeneral disorders | 314/705 | 89/191 | 299/704 |
| NeutropeniaBlood and lymphatic system disorders | 302/705 | 85/191 | 228/704 |
| StomatitisGastrointestinal disorders | 252/705 | 77/191 | 187/704 |
| Decreased AppetiteMetabolism and nutrition disorders | 177/705 | 71/191 | 160/704 |
| VomitingGastrointestinal disorders | 221/705 | 64/191 | 192/704 |
| Neuropathy PeripheralNervous system disorders | 218/705 | 49/191 | 212/704 |
| ThrombocytopeniaBlood and lymphatic system disorders | 186/705 | 55/191 | 85/704 |
| Age, Continuous(years) | Cediranib 20 mg | Bevacizumab 5 mg/kg | Cediranib 30 mg | Total |
|---|---|---|---|---|
| Mean | 58.1 ± 11.37 | 59.0 ± 10.82 | 59.2 ± 10.59 | 58.6 ± 11.1 |
| Sex: Female, Male(Participants) | Cediranib 20 mg | Bevacizumab 5 mg/kg | Cediranib 30 mg | Total |
|---|---|---|---|---|
| Female | 297 | 299 | 73 | 669 |
| Male | 412 | 414 | 119 | 945 |
Showing the first 100 of 283 sites across 28 countries. Choose a country and city above to see the rest.
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cediranib