Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00309946
Status:
COMPLETED
Last Update Posted:
2014-07-31
First Post:
2006-03-29
Brief Title:
Cediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of AZD2171 NSC732208 in Patients With Malignant Mesothelioma
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial is studying how well cediranib maleate works in treating patients with malignant mesothelioma that cannot be removed by surgery Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
Detailed Description:
We conducted a multi-center phase II trial of cediranib in patients with unresectable histologically-confirmed malignant mesothelioma MM who had received 1 prior regimen of chemotherapy The primary endpoint was objective response rate Initial cediranib dosing was 45 mg daily during a 28-day cycle Due to substantial toxicity the starting dose was subsequently lowered to 30 mg daily
Pretreatment evaluation included a medical history and physical exam complete blood count and differential chemistry panel pregnancy test and a computed tomography CT scan of the chest abdomen and pelvis if relevant A history and physical exam were repeated every 14 days and laboratory evaluations including a complete blood count with differential serum chemistry panel and urinalysis were repeated every 7 days Patients were provided with a blood pressure monitoring device and a diary to record their blood pressure readings twice daily
Patients received a minimum of 2 cycles unless unacceptable toxicity or rapid clinical progression of disease occurred Response was evaluated by CT imaging every two cycles Confirmatory scans were to be obtained at least 4 weeks after initial documentation of an objective complete or partial response
Cediranib was administered orally once daily on days 1 through 28 of a 28-day cycle Cediranib was initially dosed at 45 mg daily but due to substantial rates of toxicity the protocol was amended in June 2007 to decrease the starting dose to 30 mg daily Cediranib was taken 1 hour h before or 2 h after meals Only one dose modification was permitted When the starting cediranib dose was 45 mg dose level-1 was 30 mg daily After the protocol amendment dose level-1 was 20 mg daily Further dose reductions were allowed at the discretion of the investigator only if the patient had received clinical benefit from cediranib for 3 months Patients undergo blood collection periodically during study for biomarker and optional pharmacogenomic correlative studies After completion of study treatment patients are followed for up to 8 weeks
Adverse effects were graded according to National Cancer Institute Common Toxicity Criteria version 30 The dose was reduced for grade 3 or greater non-hematologic toxicity attributable to cediranib or grade 4 hematologic toxicity if the toxicity lasted for 5 days and did not resolve to grade 2 Maximal antihypertensive therapy was defined as taking 4 antihypertensive agents for 2 weeks at full dosage For patients on antihypertensive therapy who had an elevation in systolic blood pressure SBP 140 mmHg or diastolic blood pressure DBP 90 mmHg on 2 separate readings during a 48 h period the dose of cediranib was maintained without interruption while the dosage of current antihypertensive therapy was increased or an additional antihypertensive agent was started If 2 readings reported a SBP 180 mmHg or a DBP 105 mmHg during a 1 week period cediranib was held and there was either an increase in the dosage of current antihypertensive therapy or an additional antihypertensive agent was added Resumption of cediranib was allowed only after the blood pressure was 14090 mmHg If 2 blood pressure readings recorded an SBP 160 mmHg or a DBP 105 mmHg 1 h apart during a 48 hour period in a patient already on maximal antihypertensive therapy cediranib was held and treatment was resumed at 1 dose level lower when the blood pressure was 160105
PRIMARY OBJECTIVE
I Determine the objective response rate in patients with malignant pleural peritoneal or tunica vaginalis mesothelioma that is not amenable to curative surgery who are treated with AZD2171 cediranib maleate
SECONDARY OBJECTIVES
I Determine the progression-free survival of patients treated with AZD2171 II Determine the toxicity experienced by patients treated with AZD2171 III Determine median and overall survival of patients treated with AZD2171
TERTIARY OBJECTIVES
I Generate preliminary data regarding potential utility of pharmacogenomic and plasmaserum biomarkers of angiogenesis as predictive or prognostic markers for future investigations of this drug in malignant mesothelioma
Pretreatment evaluation included a medical history and physical exam complete blood count and differential chemistry panel pregnancy test and a computed tomography CT scan of the chest abdomen and pelvis if relevant A history and physical exam were repeated every 14 days and laboratory evaluations including a complete blood count with differential serum chemistry panel and urinalysis were repeated every 7 days Patients were provided with a blood pressure monitoring device and a diary to record their blood pressure readings twice daily
Patients received a minimum of 2 cycles unless unacceptable toxicity or rapid clinical progression of disease occurred Response was evaluated by CT imaging every two cycles Confirmatory scans were to be obtained at least 4 weeks after initial documentation of an objective complete or partial response
Cediranib was administered orally once daily on days 1 through 28 of a 28-day cycle Cediranib was initially dosed at 45 mg daily but due to substantial rates of toxicity the protocol was amended in June 2007 to decrease the starting dose to 30 mg daily Cediranib was taken 1 hour h before or 2 h after meals Only one dose modification was permitted When the starting cediranib dose was 45 mg dose level-1 was 30 mg daily After the protocol amendment dose level-1 was 20 mg daily Further dose reductions were allowed at the discretion of the investigator only if the patient had received clinical benefit from cediranib for 3 months Patients undergo blood collection periodically during study for biomarker and optional pharmacogenomic correlative studies After completion of study treatment patients are followed for up to 8 weeks
Adverse effects were graded according to National Cancer Institute Common Toxicity Criteria version 30 The dose was reduced for grade 3 or greater non-hematologic toxicity attributable to cediranib or grade 4 hematologic toxicity if the toxicity lasted for 5 days and did not resolve to grade 2 Maximal antihypertensive therapy was defined as taking 4 antihypertensive agents for 2 weeks at full dosage For patients on antihypertensive therapy who had an elevation in systolic blood pressure SBP 140 mmHg or diastolic blood pressure DBP 90 mmHg on 2 separate readings during a 48 h period the dose of cediranib was maintained without interruption while the dosage of current antihypertensive therapy was increased or an additional antihypertensive agent was started If 2 readings reported a SBP 180 mmHg or a DBP 105 mmHg during a 1 week period cediranib was held and there was either an increase in the dosage of current antihypertensive therapy or an additional antihypertensive agent was added Resumption of cediranib was allowed only after the blood pressure was 14090 mmHg If 2 blood pressure readings recorded an SBP 160 mmHg or a DBP 105 mmHg 1 h apart during a 48 hour period in a patient already on maximal antihypertensive therapy cediranib was held and treatment was resumed at 1 dose level lower when the blood pressure was 160105
PRIMARY OBJECTIVE
I Determine the objective response rate in patients with malignant pleural peritoneal or tunica vaginalis mesothelioma that is not amenable to curative surgery who are treated with AZD2171 cediranib maleate
SECONDARY OBJECTIVES
I Determine the progression-free survival of patients treated with AZD2171 II Determine the toxicity experienced by patients treated with AZD2171 III Determine median and overall survival of patients treated with AZD2171
TERTIARY OBJECTIVES
I Generate preliminary data regarding potential utility of pharmacogenomic and plasmaserum biomarkers of angiogenesis as predictive or prognostic markers for future investigations of this drug in malignant mesothelioma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 14203B | Registry Identifier | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17102 |
| N01CM17102 | NIH | None | None |
| CDR0000463521 | REGISTRY | None | None |