A Phase 2 interventional study of cediranib maleate and laboratory biomarker analysis in Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer and Recurrent Primary Peritoneal Cavity Cancer, sponsored by National Cancer Institute (NCI). Completed at 28 sites in 2 countries. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2018-08-29.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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.
720 studies on the registry are indexed under Fallopian Tube Neoplasms; 127 are open to participants now.
This study's enrollment of 74 is above the median of 52 across 589 interventional studies indexed under Fallopian Tube Neoplasms.
Browse Fallopian Tube Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: cediranib maleate · Other: laboratory biomarker analysis
30mg given PO, daily
Also known as: AZD2171, Recentin
Correlative studies
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
Time frame: After 16 weeks
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.
Time frame: Up to 4 years
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.
Time frame: 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 frame: 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%.
Time frame: Up to 4 years
Incidence of Toxicity Graded According to National Cancer Institution Common Terminology Criteria for Adverse Events Version 3.0
Time frame: Up to 4 years
| Milestone | Treatment (Cediranib Maleate) |
|---|---|
| Started | 74 |
| Completed | 74 |
| Not completed | 0 |
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
| participants | Treatment (Cediranib Maleate) |
|---|---|
| Platinum sensitive participants | 9 |
| Platinum resistant participants | 0 |
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.
| months | Treatment (Cediranib Maleate) |
|---|---|
| Platinum Sensitive Participants | 7.2 (3.9 to 9.4) |
| Platinum Resistant Participants | 3.7 (3.4 to 4.5) |
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.
| months | Treatment (Cediranib Maleate) |
|---|---|
| Overall Survival (OS) (Discontinued as of 4/25/2014) | 18.9 (13.5 to 31.5) |
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.
| months | Treatment (Cediranib Maleate) |
|---|---|
| Progression-free Survival (PFS) | 4.9 (3.9 to 7) |
Confirmed response on CA125 - defined as reduction in level of pre-treatment sample by \> 50%.
| weeks | Treatment (Cediranib Maleate) |
|---|---|
| Platinum sensitive participants | 108 |
No measurements were reported for this outcome.
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Cediranib Maleate) | — | 5/74 (6.8%) | 47/74 (63.5%) |
| Event | Treatment (Cediranib Maleate) |
|---|---|
| Sinus tachycardiaCardiac disorders | 1/74 |
| HypomagnesemiaMetabolism and nutrition disorders | 1/74 |
| Death NOSGeneral disorders | 1/74 |
| Alkaline phosphatase increasedInvestigations | 1/74 |
| BruisingInjury, poisoning and procedural complications | 1/74 |
| Event | Treatment (Cediranib Maleate) |
|---|---|
| headacheNervous system disorders | 47/74 |
| HypertensionVascular disorders | 18/74 |
| fatigueGeneral disorders | 13/74 |
| diarrheaGastrointestinal disorders | 7/74 |
| Small intestinal obstructionGastrointestinal disorders | 4/74 |
| Myocardial infarctionCardiac disorders | 2/74 |
| Thromboembolic eventVascular disorders | 2/74 |
Platinum sensitive: 39 Platinum resistant: 35 Total # treated: 74
| Age, Categorical(Participants) | Treatment (Cediranib Maleate) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 55 |
| >=65 years | 19 |
| Age, Continuous(years) | Treatment (Cediranib Maleate) |
|---|---|
| Median | 58 (31 to 87) |
| Sex: Female, Male(Participants) | Treatment (Cediranib Maleate) |
|---|---|
| Female | 74 |
| Male | 0 |
| Region of Enrollment(participants) | Treatment (Cediranib Maleate) |
|---|---|
| Canada | 52 |
| United States | 22 |
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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