Vorinostat in Combination With Radiation Therapy and Infusional Fluorouracil (5-FU) in Patients With Locally Advanced Adenocarcinoma of the Pancreas
This study is ongoing, but not recruiting participants.
Sponsor:
Massachusetts General Hospital
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Merck
Information provided by (Responsible Party):
Lawrence S. Blaszkowsky, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00948688
First received: July 27, 2009
Last updated: April 25, 2012
Last verified: April 2012
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Purpose
The durg vorinostat (Zolinza) is a type of drug called an histone deacetylase (HDAC) inhibitor. It inhibits a group of enzymes called histone deacetylases. These enzymes help cancer cells survive. By inhibiting these enzymes, vorinostat helps kill cancer cells. In this research study vorinostat will be given along with radiation therapy and the drug 5-FU. This is the first research study in which vorinostat will be given along with radiation therapy and 5-FU. The purpose of this research study is to find the highest dose of vorinostat that can be given safely along with radiation therapy and 5-FU. The investigators will also begin to get information about whether vorinostat combined with radiation and 5-FU may help to treat pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer Adenocarcinoma of the Pancreas |
Radiation: Radiation therapy Drug: 5-FU Drug: Vorinostat |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Determine the maximally tolerated dose (MTD) and tolerability of vorinostat in combination with infusional 5-FU and radiation therapy. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Progression free survival at 7 months from registration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Determine toxicity profile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Median survival, response rate and resectability rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Radiation: Radiation therapy
Once per day, 5 days a week for 6 weeks
Drug: 5-FU
Intravenously over 24 hours, 7 days per week during each week of radiation therapy
Drug: Vorinostat
Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug
Other Name: Zolinza
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically proven adenocarcinoma of the pancreas
- Evaluable disease
Must have received 3-4 months of gemcitabine-based chemotherapy and have had stable disease by RECIST criteria. Regimens include:
- gemcitabine alone
- gemcitabine and erlotinib
- gemcitabine and oxaliplatin
- gemcitabine and cisplatin
- gemcitabine and capecitabine
- 18 years of age or older
- Life expectancy of greater than 4 months
- ECOG Performance Status 0-1
- Normal organ and marrow function as outlined in the protocol
- Ability to drink at least 2 liters of fluid daily
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
- Patients must be able to swallow capsules
Exclusion Criteria:
- Chemotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Participants may not be receiving any other study agents
- Known distant metastases to any organ
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat or 5-FU
- Patients taking warfarin due to potential interactions of both 5-FU and vorinostat. Low molecular weight heparin should be substituted when appropriate
- Patients who have received upper abdominal radiation therapy which fields would overlap with that determined necessary to treat the primary tumor.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breastfeeding women
- Individuals with history of a different malignancy are ineligible unless they are deemed by the investigator to be at low risk of recurrence of that malignancy. Patients may not have a concurrent second malignancy.
- Active HIV or hepatitis
- Prior exposure to HDAC inhibitor (except valproic acid, provided there is a 30 day washout period)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948688
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Merck
Investigators
| Principal Investigator: | Lawrence Blaszkowsky, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Lawrence S. Blaszkowsky, MD, Assistant Physician, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00948688 History of Changes |
| Other Study ID Numbers: | 09-114 |
| Study First Received: | July 27, 2009 |
| Last Updated: | April 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Zolinza |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Fluorouracil |
Vorinostat Pancrelipase Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Gastrointestinal Agents Histone Deacetylase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013