Phase 2
N=26
Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Cancer
Recurrent Uterine Sarcoma · Uterine Carcinosarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00075400 ↗Enrolled (actual)
26
Serious AEs
30.4%
Results posted
May 2015
Primary outcome: Primary: Progression-free Survival (PFS) > 6 Months — 4.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- imatinib mesylate (Drug); laboratory biomarker analysis (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) > 6 Months |
4.3 | — |
| PRIMARY Incidence of Adverse Effects as Assessed by CTCAE v 3.0 |
21; 2; 0; 0; 0; 21 | — |
| SECONDARY Tumor Response |
— | — |
| SECONDARY Overall Survival |
4.1 | — |
| SECONDARY Duration of Progression Free Survival |
1.6099 | — |
| SECONDARY Initial Performance Status |
12; 10; 1 | — |
| SECONDARY Initial Histologic Grade |
0; 4; 18; 1 | — |
Summary
This phase II clinical trial studies the side effects and how well imatinib mesylate works in treating patients with uterine cancer that has failed to respond to initial chemotherapy or has re-grown after therapy. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically confirmed uterine carcinosarcoma that is persistent or recurrent with documented disease progression after appropriate local therapy; acceptable histologic type is defined as carcinosarcoma (malignant mixed Mullerian tumor), homologous or heterologous type
- All patients must have measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >= 10 mm when measured by spiral CT
- Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST; tumors within a previously irradiated field will be designated as "non-target" lesions
- Patients must not be eligible for a higher priority Gynecological Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III protocol for the same patient population
- Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2; patients who have received two prior regimens must have a GOG performance status of 0 or 1
- Recovery from effects of recent surgery, radiotherapy, or chemotherapy
- Patients should be free of active infection requiring antibiotics
- Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted
- Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration
- Patients must have had one prior chemotherapeutic regimen for management of carcinosarcoma; initial treatment may include high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
- 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
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to CTCAE v3.0 grade 1
- Platelets greater than or equal to 100,000/mcl
- Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v3.0 grade 1
- Bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0 grade 1)
- Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1)
- Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1)
- Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
- Patients who have met the pre-entry requirements
- Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception, and cannot be lactating; since interactions with the metabolism of oral contraceptives cannot be excluded, a barrier method of contraception must be used
- Patients must have tissue blocks from initial diagnosis avail
Data sourced from ClinicalTrials.gov (NCT00075400). 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.