Phase 2
N=22
Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer
Recurrent Uterine Corpus Sarcoma · Uterine Carcinosarcoma
Bottom Line
View on ClinicalTrials.gov: NCT01247571 ↗Enrolled (actual)
22
Serious AEs
31.6%
Results posted
Jul 2017
Primary outcome: Primary: Objective Tumor Response (Complete or Partial) — 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pazopanib Hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Tumor Response (Complete or Partial) |
— | — |
| PRIMARY Percentage of Participants With Progression-free Survival (PFS) at 6 Months |
15.8 | — |
| PRIMARY Number of Patients With Grade 3 or Higher Adverse Events |
3; 3; 2; 2; 2; 1 | — |
| SECONDARY Progression-free Survival |
2.0 | — |
| SECONDARY Overall Survival |
8.7 | — |
Summary
This phase II trial studies how well pazopanib hydrochloride works in treating patients with uterine cancer that has come back or has not responded to treatment. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Pazopanib hydrochloride may also stop the growth of uterine cancer by blocking blood flow to the tumor.
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically confirmed uterine carcinosarcoma which is persistent or recurrent; acceptable histological type is defined as carcinosarcoma (malignant mixed müllerian tumor), homologous or heterologous type
- Patients must have measurable disease
- Measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)
- Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded)
- Each lesion must be greater than or equal to 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam or greater than or equal to 20 mm when measured by chest x-ray
- Lymph nodes must be greater than or equal to 15 mm in short axis when measured by CT or MRI
- Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST version 1.1
- Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
- Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists
- In general, this would refer to any active GOG phase III protocol or rare tumor protocol for the same patient population
- Patients must have a GOG performance status of 0, 1, or 2
- Recovery from effects of recent surgery, radiotherapy, or chemotherapy
- Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
- Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
- Any other prior therapy (chemotherapy) directed at the malignant tumor, must be discontinued at least three weeks prior to registration
- At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: hysterectomy, resection of a lung nodule - minor: central venous access catheter placement)
- Patients must have had one prior chemotherapeutic regimen for management of carcinosarcoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen
- Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease according to the following definition:
- Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa
- Note: patients on this non-cytotoxic study are allowed to receive one additional cytotoxic chemotherapy regimen for management of recurrent or persistent disease, as defined above; however, due to the novel nature of biologic compounds, patients are encouraged to enroll on second-line non-cytotoxic studies prior to receiving additional cytotoxic therapy
- Patients must have NOT received any non-cytotoxic chemotherapy for management of recurrent or persistent disease; prior hormonal therapy is permitted
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL
- Platelets greater than or equal to 100,000/mcL
- Hemoglobin level greater than or equal to 9 g/dL
- Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)
- Urine protein/creatinine ratio (UPCR) must be less than 1 (or urinary protein less than 1.0 g/24 hours)
- Bilirubin less than or equal to 1.5 x ULN (subjects with Gilbert syndrome and elevations of indirect bilirubin only are eligible)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal
Data sourced from ClinicalTrials.gov (NCT01247571). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.