Vorinostat With XRT and 5-FU for Locally Advanced Adenocarcinoma of the Pancreas
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|ClinicalTrials.gov Identifier: NCT00948688|
Recruitment Status : Terminated (Funding was withdrawn after only 10 participants were enrolled)
First Posted : July 29, 2009
Results First Posted : May 10, 2017
Last Update Posted : May 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Adenocarcinoma of the Pancreas||Radiation: Radiation therapy Drug: 5-FU Drug: Vorinostat||Phase 1 Phase 2|
- Since we are looking for the highest dose of vorinostat that can be administered safely without severe or unmanageable side effects, not everyone who participates will receive the same dose. The dose will depend upon the number of participants enrolled on the study and how well they have tolerated their doses.
- 5-FU will be given intravenously over 24 hours 7 days per week during each week of radiation therapy. In order for participants to be able to receive the 5-FU as an outpatient, they will need to have central line catheter placed.
- Radiation therapy will be given once per day, 5 days per week, for 6 weeks.
- Vorinostat is taken orally.
- Participants will be seen once per week during the 6 weeks that they are receiving 5-FU, radiation therapy and vorinostat.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/2 Study of Vorinostat in Combination With Radiation Therapy and Infusional 5-FU in Patients With Locally Advanced Adenocarcinoma of the Pancreas|
|Study Start Date :||August 2009|
|Primary Completion Date :||June 2012|
|Study Completion Date :||November 2013|
Experimental: Vorinostat, 5-FU, Radiation Therapy
Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
Radiation: Radiation therapy
Once per day, 5 days a week for 6 weeksDrug: 5-FU
Intravenously over 24 hours, 7 days per week during each week of radiation therapy
Other Name: Efudex, Carac, Fluoroplex, AdrucilDrug: Vorinostat
Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug
Other Name: Zolinza
- Maximally Tolerated Dose (MTD) of Vorinostat in Combination With Infusional 5-FU and Radiation Therapy. [ Time Frame: 6 weeks ]The maximum tolerated dose (MTD) is defined as one dose level below the dose level at which participants experience an unacceptable rate of dose-limiting toxicity.
- Progression Free Survival (PFS) at 7 Months From Registration [ Time Frame: 7 months ]Progression free survival was defined as the duration of time from registration on study to time of objective disease progression. Death was regarded as a progression event. Progression was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions as seen on radiologic evaluation.
- Progression Free Survival [ Time Frame: 2 years ]Progression free survival for this endpoint was defined as the duration of time from beginning of the patients' initial chemotherapy to time of objective disease progression. Death was regarded as a progression event. Progression was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions as seen on radiologic evaluation.
- Number of Participants Experiencing Unacceptable Toxicity [ Time Frame: 1 year ]All participants who receive at least one dose of study treatment were evaluable for toxicity. Unacceptable toxicity is based on the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Most grade 3 (severe) or 4 (life-threatening) events are considered to be unacceptable toxicities -- exceptions include nausea or vomiting, fatigue, and alopecia. Hematologic toxicities need to be either grade 4 or last for protocol-defined durations to be considered unacceptable.
- Overall Survival [ Time Frame: 1 year ]Percentage of participants still alive at 1 year after enrollment on study
- Response Rate [ Time Frame: 1 year ]Participants who have either a complete response (disappearance of all target lesions), partial response (at least 30% decrease in sum of longest diameter of target lesions) or stable disease (decrease in size of less than 30% or increase in size of less than 20%).
- Resectability Rate [ Time Frame: 5 months ]Percentage of patients able to undergo surgical resection after protocol therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948688
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Lawrence Blaszkowsky, MD||Massachusetts General Hospital|