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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-03027 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| NCI-7129 | |||
| PMH-PHL-037 | |||
| PHL-037 | Other Identifier | Princess Margaret Hospital Phase 2 Consortium | |
| 7129 | Other Identifier | CTEP | |
| N01CM62209 | U.S. NIH Grant/Contract | View source | |
| N01CM62201 | U.S. NIH Grant/Contract | View source | |
| N01CM62203 | U.S. NIH Grant/Contract | View source |
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This phase II trial is studying how well cediranib maleate works in treating patients with persistent, recurrent, or refractory advanced ovarian epithelial, peritoneal cavity, or fallopian tube cancer. Cediranib maleate may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. Objective tumor response rate (complete plus partial response plus stable disease > 16 weeks as defined by the Response Evaluation Criteria in Solid Tumors [RECIST] criteria) in women with recurrent or refractory advanced ovarian or primary peritoneal cancer.
SECONDARY OBJECTIVES:
I. Time to disease progression, median survival time, and duration of overall cancer antigen (CA)-125 response.
OUTLINE:
Patients receive cediranib maleate orally (PO) once daily (QD) every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks and then every 3 months thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (cediranib maleate) | Experimental | Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cediranib maleate | Drug | 30mg given PO, daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Benefit (Complete Response or Partial Response or Stable Disease) Based on the RECIST/Rustin Criteria | Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR+PR | After 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Disease Progression | Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible. | Up to 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holger Hirte | Princess Margaret Hospital Phase 2 Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| University of Southern California/Norris Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25895616 | Derived | Hirte H, Lheureux S, Fleming GF, Sugimoto A, Morgan R, Biagi J, Wang L, McGill S, Ivy SP, Oza AM. A phase 2 study of cediranib in recurrent or persistent ovarian, peritoneal or fallopian tube cancer: a trial of the Princess Margaret, Chicago and California Phase II Consortia. Gynecol Oncol. 2015 Jul;138(1):55-61. doi: 10.1016/j.ygyno.2015.04.009. Epub 2015 Apr 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Cediranib Maleate) | Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given PO laboratory biomarker analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| laboratory biomarker analysis | Other | Correlative studies |
|
| Overall Survival (OS) (Discontinued as of 4/25/2014) |
The Kaplan-Meier method will be used to estimate OS. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible. |
| From date of radomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 32 months. |
| Progression-free Survival (PFS) | The Kaplan-Meier method will be used to estimate PFS. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions. | Time from start of treatment to time of progression, assessed up to 6 months |
| Duration of Overall CA-125 Response | Confirmed response on CA125 - defined as reduction in level of pre-treatment sample by > 50%. | Up to 4 years |
| Incidence of Toxicity Graded According to National Cancer Institution Common Terminology Criteria for Adverse Events Version 3.0 | Up to 4 years |
| Los Angeles |
| California |
| 90033 |
| United States |
| City of Hope Medical Group Inc | Pasadena | California | 91105 | United States |
| University of California at Davis Cancer Center | Sacramento | California | 95817 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Evanston Hospital CCOP | Evanston | Illinois | 60201 | United States |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Joliet Oncology-Hematology Associates Limited | Joliet | Illinois | 60435 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Peoria Gynecologic Oncology | Peoria | Illinois | 61603 | United States |
| Oncology/Hematology Associates | Peoria | Illinois | 61615-7828 | United States |
| Central Illinois Hematology Oncology Center | Springfield | Illinois | 60702 | United States |
| Fort Wayne Medical Oncology and Hematology Inc-Parkview | Fort Wayne | Indiana | 46845 | United States |
| Northern Indiana Cancer Research Consortium | South Bend | Indiana | 46628 | United States |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0944 | United States |
| Oncology Care Associates PLLC | Saint Joseph | Michigan | 49085 | United States |
| Saint John's Mercy Medical Center | St Louis | Missouri | 63141 | United States |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15232 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Ontario | L8V 5C2 | Canada |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario | K7L 5P9 | Canada |
| London Health Sciences Centre-South Street | London | Ontario | N6A 4G5 | Canada |
| London Regional Cancer Program | London | Ontario | N6A 4L6 | Canada |
| The Ottawa Hospital Cancer Centre (Ottawa Health Research Institute) Civic Campus | Ottawa | Ontario | K1Y 4E9 | Canada |
| University Health Network-Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| CHUM - Hopital Notre-Dame | Montreal | Quebec | H2L 4M1 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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Platinum sensitive: 39 Platinum resistant: 35 Total # treated: 74
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Cediranib Maleate) | Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given PO laboratory biomarker analysis: Correlative studies |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response Benefit (Complete Response or Partial Response or Stable Disease) Based on the RECIST/Rustin Criteria | Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR+PR | Total # of Patients 74 PL-S (platinum sensitive) 39 patients PL-R (platinum resistant) 35 patients Confirmed PR PL-S group 9/39 patients Confirmed PR PL-R group 0/35 patients | Posted | Number | participants | After 16 weeks |
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| Secondary | Time to Disease Progression | Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible. | Platinum sensitive cohort | Posted | Median | 95% Confidence Interval | months | Up to 4 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) (Discontinued as of 4/25/2014) | The Kaplan-Meier method will be used to estimate OS. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible. | Posted | Median | 95% Confidence Interval | months | From date of radomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 32 months. |
|
| |||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | The Kaplan-Meier method will be used to estimate PFS. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions. | Posted | Median | 95% Confidence Interval | months | Time from start of treatment to time of progression, assessed up to 6 months |
|
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| Secondary | Duration of Overall CA-125 Response | Confirmed response on CA125 - defined as reduction in level of pre-treatment sample by > 50%. | 1 confirmed PR observed in PS group. Response will be defined as reduction in level of pre-treatment sample by > 50%. 0 confirmed PR observed in PR group. | Posted | Number | weeks | Up to 4 years |
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| Secondary | Incidence of Toxicity Graded According to National Cancer Institution Common Terminology Criteria for Adverse Events Version 3.0 | Data were not collected. | Posted | Up to 4 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Cediranib Maleate) | Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given PO laboratory biomarker analysis: Correlative studies | 5 | 74 | 47 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Death NOS | General disorders | Systematic Assessment |
| ||
| Alkaline phosphatase increased | Investigations | Systematic Assessment |
| ||
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| fatigue | General disorders | Systematic Assessment |
| ||
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hal Hirte | Juarvinski Cancer Centre | 905-387-9495 | hirteh@hhsc.ca |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C500926 | cediranib |
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