Cediranib Maleate in Treating Patients With Persistent, Recurrent, or Refractory Advanced Ovarian Epithelial, Peritoneal Cavity, or Fallopian Tube Cancer
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| ClinicalTrials.gov Identifier: NCT00278343 |
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Recruitment Status :
Completed
First Posted : January 18, 2006
Results First Posted : July 2, 2017
Last Update Posted : August 29, 2018
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Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Recurrent Fallopian Tube Cancer Recurrent Ovarian Epithelial Cancer Recurrent Primary Peritoneal Cavity Cancer | Drug: cediranib maleate Other: laboratory biomarker analysis | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 74 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2 Study of AZD2171 in Recurrent or Persistent Ovarian, Peritoneal, or Fallopian Tube Cancer |
| Study Start Date : | April 2006 |
| Actual Primary Completion Date : | June 2010 |
| Actual Study Completion Date : | January 15, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ovarian cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment (cediranib maleate)
Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.
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Drug: cediranib maleate
30mg given PO, daily
Other Names:
Other: laboratory biomarker analysis Correlative studies |
Primary Outcome Measures :
- Response Benefit (Complete Response or Partial Response or Stable Disease) Based on the RECIST/Rustin Criteria [ Time Frame: After 16 weeks ]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
Secondary Outcome Measures :
- Time to Disease Progression [ Time Frame: Up to 4 years ]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.
- Overall Survival (OS) (Discontinued as of 4/25/2014) [ 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. ]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.
- Progression-free Survival (PFS) [ Time Frame: Time from start of treatment to time of progression, assessed up to 6 months ]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.
- Duration of Overall CA-125 Response [ Time Frame: Up to 4 years ]Confirmed response on CA125 - defined as reduction in level of pre-treatment sample by > 50%.
- Incidence of Toxicity Graded According to National Cancer Institution Common Terminology Criteria for Adverse Events Version 3.0 [ Time Frame: Up to 4 years ]
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| Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has recurred or is refractory to initial therapy; patients must have received platinum-based chemotherapy before entry into this protocol
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan OR patients must have evidence of progression based on an elevated CA-125 (defined as a value of > 2 x upper limit of normal [ULN] documented on two separate determinations made > 2 weeks apart) if the physical exam is normal and CT scan of the chest/abdomen/pelvis, has a disease volume < 1 cm in maximum diameter
- Patients may have received no more than one prior chemotherapy regimen (i.e. initial first-line chemotherapy only)
- Life expectancy of greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- Leukocytes >= 3,000/mcL
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Hemoglobin >= 8 g/dL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 × institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- Women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients with borderline tumors or tumors of low malignant potential
- Patients with current bowel obstruction
- Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 30 days
- Patients with known brain metastases should be excluded from this clinical trial
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171 (cediranib maleate)
- Mean corrected QT (QTc) > 470 msec (with Bazett's correction) in screening electrocardiogram or history of familial long QT syndrome
- Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart
- Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study, breastfeeding should be discontinued if the mother is treated with AZD2171
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
- Any significant abnormality noted in the electrocardiogram (ECG) within 14 days of treatment
- A New York Heart Association classification of III or IV (NOTE: patients classified as class II controlled with treatment may continue with increase monitoring)
- Conditions requiring concurrent use of drugs or biologics with proarrythmic potential; these drugs are prohibited during studies with AZD2171
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00278343
Locations
Show 28 study locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Holger Hirte | Princess Margaret Hospital Phase 2 Consortium |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00278343 |
| Other Study ID Numbers: |
NCI-2012-03027 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 ) N01CM62201 ( U.S. NIH Grant/Contract ) N01CM62203 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 18, 2006 Key Record Dates |
| Results First Posted: | July 2, 2017 |
| Last Update Posted: | August 29, 2018 |
| Last Verified: | July 2018 |
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms Carcinoma, Ovarian Epithelial Recurrence Disease Attributes Pathologic Processes Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Genital Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Ovarian Neoplasms Endocrine Gland Neoplasms Ovarian Diseases Endocrine System Diseases Gonadal Disorders Cediranib Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Protein Kinase Inhibitors |