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
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.
Study Phase
Phase 2
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
CP-547,632
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
December 2004
Completion Date
February 2005
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Mark D. Pegram, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00096239
Organization ID
CDR0000390237
Secondary IDs
UCLA-0311057-01
Study Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Mark D. Pegram, MD, Principal Investigator, Jonsson Comprehensive Cancer Center
Verification Date
February 2005