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CP-547,632 in Treating Patients With Recurrent or Persistent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CP-547,632
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, primary peritoneal serous, or fallopian tube cancer Recurrent or persistent disease Elevated CA 125, defined as ≥ 40 U/mL on 2 separate consecutive measurements taken ≥ 1 week apart No definitive disease OR small-volume disease (≤ 2 cm by spiral or conventional CT scan or clinical exam) Asymptomatic disease PATIENT CHARACTERISTICS: Age 26 and over (age 18 to 25 allowed provided there is closure of the epiphyses on radiography) Performance status ECOG 0-1 Life expectancy More than 6 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 No bleeding disorders No hemorrhage ≥ grade 2 within the past 12 months Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN ALT and/or AST ≤ 2.5 times ULN Albumin ≥ 3.2 g/dL PT/PTT ≤ 1.5 times ULN INR ≤ 1.5 Renal Creatinine ≤ 1.5 times ULN OR Creatinine clearance ≥ 60 mL/min Cardiovascular QTc ≤ 460 msec by ECG No unstable angina within the past 6 months No decompensated congestive heart failure within the past 6 months No myocardial infarction within the past 6 months No serious cardiac arrhythmias or conduction abnormalities, including any history of recurrent ventricular arrhythmia, within the past 6 months No cardiomyopathy No history of syncope associated with arrhythmia No uncontrolled hypertension within the past 3 weeks, defined as systolic blood pressure > 150 mm Hg or diastolic blood pressure > 90 mm Hg on ≥ 2 of 3 blood pressure readings taken ≥ 5 minutes apart No thrombotic cardiovascular events, including transient ischemic attacks, within the past 12 months Gastrointestinal Able to take oral medication No malabsorption syndromes No active gastrointestinal bleeding (hematemesis, hematochezia, or melena), unrelated to cancer, within the past 3 months No requirement for IV alimentation Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No active infection No uncontrolled diabetes No dementia, altered mental status, or uncontrolled psychiatric illness that would preclude giving informed consent or study compliance No other serious uncontrolled medical disorder that would preclude study participation No other active malignancy within the past 3 years except treated limited stage basal cell or squamous cell skin cancer or carcinoma in situ of the breast or cervix PRIOR CONCURRENT THERAPY: Biologic therapy No prior exposure to mouse antibodies No prior vascular endothelial growth factor (VEGF) or VEGF-receptor targeted therapy No other prior antiangiogenic anticancer therapy, including thalidomide No concurrent prophylactic colony-stimulating factors (i.e., filgrastim [G-CSF] or sargramostim [GM-CSF]) No concurrent immunotherapy Chemotherapy Prior chemotherapy allowed provided patient received only a first-line platinum-based chemotherapy regimen with or without systemic consolidation chemotherapy At least 3 weeks since prior chemotherapy and recovered (excluding alopecia) No concurrent chemotherapy Endocrine therapy At least 3 weeks since prior hormonal therapy for ovarian cancer and recovered Concurrent hormone replacement therapy allowed No concurrent chronic oral or IV corticosteroids No concurrent hormonal therapy, including tamoxifen Radiotherapy No concurrent radiotherapy Surgery More than 4 weeks since prior major surgical procedure No prior gastric resection Other More than 3 weeks since prior investigational therapy More than 4 weeks since prior major medical interference with the peritoneum or pleura More than 3 months since prior treatment for active ulcer disease No prior consolidation intraperitoneal therapy using cytotoxic agents for ovarian cancer No concurrent antiarrhythmics Beta blockers or calcium channel blockers used for other indications allowed No concurrent grapefruit juice No concurrent therapeutic anticoagulant therapy or chronic daily aspirin > 325 mg/day Concurrent low-dose anticoagulants for maintenance of central venous access allowed No other concurrent experimental or anticancer therapy for the primary disease

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 9, 2004
Last Updated
December 18, 2013
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00096239
Brief Title
CP-547,632 in Treating Patients With Recurrent or Persistent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2005
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: CP-547,632 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-547,632 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-547,632, 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-547,632 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CP-547,632

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, primary peritoneal serous, or fallopian tube cancer Recurrent or persistent disease Elevated CA 125, defined as ≥ 40 U/mL on 2 separate consecutive measurements taken ≥ 1 week apart No definitive disease OR small-volume disease (≤ 2 cm by spiral or conventional CT scan or clinical exam) Asymptomatic disease PATIENT CHARACTERISTICS: Age 26 and over (age 18 to 25 allowed provided there is closure of the epiphyses on radiography) Performance status ECOG 0-1 Life expectancy More than 6 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 No bleeding disorders No hemorrhage ≥ grade 2 within the past 12 months Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN ALT and/or AST ≤ 2.5 times ULN Albumin ≥ 3.2 g/dL PT/PTT ≤ 1.5 times ULN INR ≤ 1.5 Renal Creatinine ≤ 1.5 times ULN OR Creatinine clearance ≥ 60 mL/min Cardiovascular QTc ≤ 460 msec by ECG No unstable angina within the past 6 months No decompensated congestive heart failure within the past 6 months No myocardial infarction within the past 6 months No serious cardiac arrhythmias or conduction abnormalities, including any history of recurrent ventricular arrhythmia, within the past 6 months No cardiomyopathy No history of syncope associated with arrhythmia No uncontrolled hypertension within the past 3 weeks, defined as systolic blood pressure > 150 mm Hg or diastolic blood pressure > 90 mm Hg on ≥ 2 of 3 blood pressure readings taken ≥ 5 minutes apart No thrombotic cardiovascular events, including transient ischemic attacks, within the past 12 months Gastrointestinal Able to take oral medication No malabsorption syndromes No active gastrointestinal bleeding (hematemesis, hematochezia, or melena), unrelated to cancer, within the past 3 months No requirement for IV alimentation Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No active infection No uncontrolled diabetes No dementia, altered mental status, or uncontrolled psychiatric illness that would preclude giving informed consent or study compliance No other serious uncontrolled medical disorder that would preclude study participation No other active malignancy within the past 3 years except treated limited stage basal cell or squamous cell skin cancer or carcinoma in situ of the breast or cervix PRIOR CONCURRENT THERAPY: Biologic therapy No prior exposure to mouse antibodies No prior vascular endothelial growth factor (VEGF) or VEGF-receptor targeted therapy No other prior antiangiogenic anticancer therapy, including thalidomide No concurrent prophylactic colony-stimulating factors (i.e., filgrastim [G-CSF] or sargramostim [GM-CSF]) No concurrent immunotherapy Chemotherapy Prior chemotherapy allowed provided patient received only a first-line platinum-based chemotherapy regimen with or without systemic consolidation chemotherapy At least 3 weeks since prior chemotherapy and recovered (excluding alopecia) No concurrent chemotherapy Endocrine therapy At least 3 weeks since prior hormonal therapy for ovarian cancer and recovered Concurrent hormone replacement therapy allowed No concurrent chronic oral or IV corticosteroids No concurrent hormonal therapy, including tamoxifen Radiotherapy No concurrent radiotherapy Surgery More than 4 weeks since prior major surgical procedure No prior gastric resection Other More than 3 weeks since prior investigational therapy More than 4 weeks since prior major medical interference with the peritoneum or pleura More than 3 months since prior treatment for active ulcer disease No prior consolidation intraperitoneal therapy using cytotoxic agents for ovarian cancer No concurrent antiarrhythmics Beta blockers or calcium channel blockers used for other indications allowed No concurrent grapefruit juice No concurrent therapeutic anticoagulant therapy or chronic daily aspirin > 325 mg/day Concurrent low-dose anticoagulants for maintenance of central venous access allowed No other concurrent experimental or anticancer therapy for the primary disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D. Pegram, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

Learn more about this trial

CP-547,632 in Treating Patients With Recurrent or Persistent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

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