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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Mark D. Pegram, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000390237

NCT ID:

NCT00096239

Start Date:

December 2004

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • fallopian tube cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781