Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096239
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2004-11-09
Brief Title:
CP-547632 in Treating Patients With Recurrent or Persistent Ovarian Cancer Primary Peritoneal Cancer or Fallopian Tube Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Open-Label Multi-Center Study of CP-547 632 an Oral Tyrosine Kinase Inhibitor of VEGFR-2 in Subjects With Recurrent or Persistent Small-Volume Epithelial Ovarian Cancer Primary Peritoneal Serous Cancer or Fallopian Tube Cancer
Status:
COMPLETED
Status Verified Date:
2005-02
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:
RATIONALE CP-547632 may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor
PURPOSE This phase II trial is studying how well CP-547632 works in treating patients with recurrent or persistent ovarian cancer primary peritoneal cancer or fallopian tube cancer
PURPOSE This phase II trial is studying how well CP-547632 works in treating patients with recurrent or persistent ovarian cancer primary peritoneal cancer or fallopian tube cancer
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of CP-547632 in terms of clinical response benefit CA 125 response complete response CR or partial response PR or stable disease 16 weeks in patients with recurrent or persistent small-volume ovarian epithelial primary peritoneal serous or fallopian tube cancer
Secondary
Determine progression-free survival of patients treated with this drug
Determine CA 125 response CR or PR rate in patients treated with this drug
Determine duration of CA 125 response in patients treated with this drug
Determine the safety of this drug in these patients
Correlate the steady state plasma concentration of this drug with efficacy and toxicity in these patients
Correlate clinical outcome with an angiogenic profile derived from measurement of serum vascular endothelial growth factor basic fibroblast growth factor and interleukin-8 in patients treated with this drug
Determine changes in the Hospital Anxiety and Depression Scale HADS in patients treated with this drug
OUTLINE This is an open-label multicenter study
Patients receive oral CP-547632 once daily on days 1-28 Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 30 days and then every 3 months for 2 years
PROJECTED ACCRUAL A total of 10-29 patients will be accrued for this study within 1 year
Primary
Determine the efficacy of CP-547632 in terms of clinical response benefit CA 125 response complete response CR or partial response PR or stable disease 16 weeks in patients with recurrent or persistent small-volume ovarian epithelial primary peritoneal serous or fallopian tube cancer
Secondary
Determine progression-free survival of patients treated with this drug
Determine CA 125 response CR or PR rate in patients treated with this drug
Determine duration of CA 125 response in patients treated with this drug
Determine the safety of this drug in these patients
Correlate the steady state plasma concentration of this drug with efficacy and toxicity in these patients
Correlate clinical outcome with an angiogenic profile derived from measurement of serum vascular endothelial growth factor basic fibroblast growth factor and interleukin-8 in patients treated with this drug
Determine changes in the Hospital Anxiety and Depression Scale HADS in patients treated with this drug
OUTLINE This is an open-label multicenter study
Patients receive oral CP-547632 once daily on days 1-28 Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 30 days and then every 3 months for 2 years
PROJECTED ACCRUAL A total of 10-29 patients will be accrued for this study within 1 year
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-0311057-01 | None | None | None |
| PFIZER-A3521003 | None | None | None |