Clinical trial · Interventional
CP-547,632 in Treating Patients With Recurrent or Persistent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CP-547,632 | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 diseaseReferences
Publications (0)
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