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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096239
• Other study ID #: CDR0000390237
• Secondary ID: UCLA-0311057-01P
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2004
• Last updated: December 18, 2013
• Start date: December 2004
• Est. completion date: February 2005

Study information

• Verified date: February 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• CP-547,632

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,