AZD2171 in Treating Patients With Persistent, Recurrent, or Refractory Advanced Ovarian Epithelial, Peritoneal Cavity, or Fallopian Tube Cancer
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: AZD2171 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.
PURPOSE: This phase II trial is studying how well AZD2171 works in treating patients with persistent, recurrent, or refractory advanced ovarian epithelial, peritoneal cavity, or fallopian tube cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: cediranib maleate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of AZD2171 in Recurrent or Persistent Ovarian, Peritoneal, or Fallopian Tube Cancer |
- Objective tumor response rate (complete and partial response and stable disease) for ≥ 16 weeks as assessed by RECIST criteria [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
- Progression-free and overall survival at the median time-point and 6 months [ Designated as safety issue: No ]
- Response duration [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Duration of overall CA-125 antigen response [ Designated as safety issue: No ]
| Estimated Enrollment: | 64 |
| Study Start Date: | March 2006 |
| Estimated Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Determine the objective response rate (complete response, partial response, and stable disease for ≥ 16 weeks) in patients with persistent, recurrent, or refractory advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer treated with AZD2171.
Secondary
- Determine the time to disease progression, median survival time, and duration of overall CA-125 antigen response in these patients.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to reaction to prior platinum-based regimen (sensitive vs insensitive).
Patients receive oral AZD2171 once daily for 4 weeks. Courses repeat every 4 weeks for up to 8 months in the absence of disease progression or toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 64 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
- Persistent, recurrent, or refractory to initial therapy
- Advanced disease
Measurable or evaluable disease, as defined by 1 of the following:
- At least 1 lesion measured in at least 1 dimension as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
- Evidence of progression based on an elevated CA-125 (defined as a value of ≥ 2 times upper limit of normal [ULN] documented on two separate determinations made > 2 weeks apart) if the physical exam is normal and CT scan has a disease volume < 1 cm in maximum diameter
- No borderline tumors or tumors of low malignant potential
Patients must have received platinum-based chemotherapy prior to study entry
- No more than 1 prior chemotherapy regimen (i.e., initial first-line chemotherapy only)
- No known brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2
- Karnofsky PS > 60-100%
- Life expectancy > 12 weeks
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8 g/dL
- Bilirubin normal
- ALT and AST ≤ 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No bowel obstruction
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171
- Mean QTc ≤ 470 msec (with Bazett's correction)
- No history of familial long QT syndrome
- No psychiatric illness or social situation that would limit compliance with study requirements
- No uncontrolled illness
- No HIV-positive patients on combination antiretroviral therapy
- No greater that +1 proteinuria on 2 consecutive dipsticks taken no less than 1 week apart
- No significant abnormality as seen by ECG within 14 days of treatment
No New York Heart Associated class III or IV disease
- Class II disease controlled with treatment and increased monitoring is allowed
- No hypertension
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy, or major surgery
- No concurrent drugs or biologic agents with proarrhythmic potential
- No other investigational agents or participation in an investigational trial within 30 days prior to study entry
- No other concurrent anticancer agents or therapies
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Canada, Ontario | |
| Margaret and Charles Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| London Regional Cancer Program at London Health Sciences Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Ottawa Hospital Regional Cancer Centre - General Campus | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| Hopital Notre-Dame du CHUM | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Study Chair: | Hal W. Hirte, MD, FRCP(C) | Margaret and Charles Juravinski Cancer Centre |
More Information
Additional Information:
Publications:
| Responsible Party: | Amit M. Oza, Princess Margaret Hospital |
| ClinicalTrials.gov Identifier: | NCT00278343 History of Changes |
| Other Study ID Numbers: | CDR0000456204, PMH-PHL-037, NCI-7129 |
| Study First Received: | January 16, 2006 |
| Last Updated: | April 14, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
recurrent ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms |
Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Maleic acid Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013