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

NCT00096239 | Completed Phase 2

• 3 other identifiers: CDR0000390237UCLA-0311057-01PFIZER-A3521003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; primary peritoneal cavity cancer; fallopian tube cancer

Interventions

CP-547,632 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

3-(4-bromo-2,6-difluorobenzyloxy)-5-(3-(4-pyrrolidin-1-ylbutyl)ureido)isothiazole-4-carboxylic acid amide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Mark D. Pegram, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 9, 2004
• Study Start: December 1, 2004
• Study Completion: February 1, 2005
• Last Updated: December 19, 2013

Record last verified: 2005-02

Locations

US (1)