Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder
The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of advanced or metastatic bladder cancer. The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this patient population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this patient population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body).
Carcinoma, Transitional Cell
Drug: Pralatrexate Injection
Dietary Supplement: Vitamin B12
Dietary Supplement: Folic Acid
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2, Single-Arm Study of Pralatrexate in Patients With Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder|
- Objective Response Rate (ORR) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended for up to 2 years after enrollment. ] [ Designated as safety issue: No ]The number of patients with a best overall confirmed response of either complete response (CR) or partial response (PR)
- Duration of Response (DOR) [ Time Frame: Measured from the first day of documented response for up to 2 years after enrollment. ] [ Designated as safety issue: No ]Duration of time from when tumor measurement criteria were met for CR or PR (whichever status was recorded first) until the first date that recurrent disease or progressive disease (PD) or death was objectively documented. Progression is defined, using RECIST, as an increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. Calculated for those patients with a best overall confirmed or unconfirmed response of CR or PR.
- Clinical Benefit Rate (CBR) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks) or per standard of care, but no more than every 12 weeks (+/- 1 week) if treatment has ended, for up to 2 years after enrollment. ] [ Designated as safety issue: No ]The number of patients with a best confirmed or unconfirmed response of CR, PR, or stable disease (SD) for at least 24 weeks (approximately 5.5 months)
- Progression Free Survival (PFS) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended, for up to 2 years after enrollment. ] [ Designated as safety issue: No ]Length of time from study day 1 to the date of radiological evidence of PD (date of computed tomography [CT] or magnetic resonance imaging [MRI] scan, whichever indicates PD) or death, regardless of cause.
- Overall Survival (OS) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care if treatment has ended (at least every 12 weeks) for up to 2 years after enrollment. After PD or start of subsequent treatment, OS will be assessed every 4 months. ] [ Designated as safety issue: No ]The number of days from study day 1 to death. Patients who had not died (no record of death) or were lost to follow-up were censored at the date of last contact.
|Study Start Date:||July 2008|
|Study Completion Date:||September 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Drug: Pralatrexate Injection
- Vitamin B9
Intravenous (IV) push administration over 3-5 minutes via a peripheral IV line containing normal saline (0.9% sodium chloride).
Initial dose: 190 mg/m2
Dose reductions per protocol: 150 mg/m2, 120 mg/m2 and 100 mg/m2 will be allowed for defined toxicity.
Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met.
1 mg intramuscular injection
Administered within 10 weeks of enrollment, every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate.
1-1.25 mg orally
Administered daily for at least 7 days prior to enrollment, throughout the study and for at least 30 days after last dose of pralatrexate.
|United States, Arizona|
|The University of Arizona Health Sciences Center|
|Tucson, Arizona, United States, 85724|
|United States, Georgia|
|Peachtree Hematology/Oncology Consultants|
|Atlanta, Georgia, United States, 30318|
|United States, New York|
|University of Rochester Cancer Center|
|Rochester, New York, United States, 14642|
|United States, Utah|
|University of Utah, Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Centro de Terapia Radiante Cumbres (CAICI)|
|Rosario, Santa Fe, Argentina, 2000|
|IONC (Instituto Oncológuci de Cordoba)|
|Cordoba, Argentina, X5004BAL|
|Algemeen Ziekenhuis Middelheim|
|Antwerp, Belgium, 2020|
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|CH Split Clinic of Oncology and Radiotherapy|
|Split, Croatia, 21000|
|Clinic of Oncology and Nuclear Medicine, CH "Sestre Milosrdnice"|
|Zagreb, Croatia, 10000|
|CHU Zagreb University Hospital Center Rebro in Zagreb|
|Zagreb, Croatia, 10000|
|Institut Sainte Catherine|
|Avignon, France, 84082|
|Centre Oscar Lambret|
|Lille Cedex, France, 59020|
|Centre Hospitalier Rene Dubos|
|Pontoise, France, 95301|
|Institut Gustave Roussy|
|Villejuif Cedex, France, 94 805|
|Hospital Del Mar - Barcelona|
|Barcelona, Spain, 8003|
|Ciutat Sanitari de Vall d'Hebron|
|Barcelona, Spain, 08035|
|Hospital Virgen del Rocio|
|Sevilla, Spain, 41013|
|Study Director:||Garry Weems, Pharm.D.||Spectrum Pharmaceuticals, Inc|