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About
This phase II trial studies how well pemetrexed disodium works in treating patients with previously treated urothelial cancer that has spread from the primary site (place where it started) to other places in the body. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Full description
PRIMARY OBJECTIVES:
To determine the objective response rates (ORR) to pemetrexed disodium (pemetrexed) in patients with MTAP-deficient metastatic bladder cancer.
SECONDARY OBJECTIVES:
I. To determine the progression-free survival (PFS) for patients with MTAP-deficient metastatic bladder cancer treated with pemetrexed.
II. To determine the overall survival (OS) for patients with MTAP-deficient metastatic bladder cancer treated with pemetrexed.
III. Evaluate the toxicity of pemetrexed therapy for patients with MTAP-deficient metastatic bladder cancer.
IV. Collect blood, urine, and tissue for future translational studies.
OUTLINE:
Patients receive pemetrexed disodium intravenously (IV) over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 weeks and then every 3 months for 5 years.
Enrollment
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Inclusion criteria
Patients must have histological confirmation of metastatic urothelial carcinoma; patients must have sufficient tumor tissues for future MTAP testing and research; histological variants such as glandular, squamous, sarcomatoid, micropapillary, plasmacytoid, and small cell changes will not be allowed for this trial unless these tumors are MTAP-deficient
All patients must have measurable disease and tumors of sufficient sizes for biopsy; in general, liver and lung lesions should be at least 1.0 cm, and patients with lymph node-only disease should have lesions of >= 1.5 cm in shortest dimension; patients with disease confined to bone may be eligible if a measurable lytic defect is present; the study principal investigator (PI) is the final arbiter in questions related to measurability; patients with a three-dimensional mass or pelvic sidewall fixation on bladder examination under anesthesia are considered to have measurable disease
Patients who have received any non-anti-folate containing neoadjuvant or systemic chemotherapy are eligible; any prior intravesical therapy, or immunotherapy is allowed
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x upper limit normal (ULN), or =< 5 x ULN if documented liver metastases are present
Total bilirubin =< 1.5 x ULN, except subjects with Gilbert's syndrome or liver metastases, who must have a baseline total bilirubin =< 3.0 mg/dL
Absolute neutrophil count (ANC) >= 1500
Platelets >= 100,000
Normal serum creatinine, or a creatinine clearance >= 40 ml/min (either measured using a 24 hour urine, calculated using Cockroft-Gault, or estimated using the Modification of Diet in Renal Disease [MDRD] method from the National Kidney Disease Education Program [NKDEP] [the method reported by M D Anderson Cancer Center (MDACC) laboratories])
Females of childbearing potential who are sexually active with a non-sterilized male partner and non-sterilized males must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 180 days after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician
Females of childbearing potential must also refrain from egg cell donation for 180 days after the final dose of investigational product;
The ability to interrupt nonsteroidal antiinflammatory drug (NSAIDS) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed
The ability to take folic acid, vitamin B12, and dexamethasone according to protocol
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7 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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