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A Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors
This study has been completed.
First Received: September 20, 2006   Last Updated: September 3, 2008   History of Changes
Sponsored by: Gloucester Pharmaceuticals
Information provided by: Gloucester Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00379639
  Purpose

This is a phase I/II dose escalation trial designed to determine the maximum tolerated dose (MTD) for the combination of romidepsin (depsipeptide) and gemcitabine.


Condition Intervention Phase
Pancreatic Cancer
Drug: Romidepsin (Depsipeptide)/Gemcitabine
Phase I
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine Gemcitabine hydrochloride FR 901228
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I/II Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors.

Further study details as provided by Gloucester Pharmaceuticals:

Primary Outcome Measures:
  • Toxicities will be assessed according to the NCI CTCAE grading system. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Safety will be evaluated using clinical examination, laboratory screens, and documentation of all adverse events and serious adverse events. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Objective disease response will be evaluated according to RECIST guidelines. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2006
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Romidepsin (Depsipeptide)/Gemcitabine

    Patients will receive 7,10, or 12 mg/m2 of romidepsin IV over 4 hours on either Days 1,8 and 15 or Days 1 and 15 of each 28-day cycle. Subsequent doses of romidepsin will based on treatment-related toxicities.

    Patients will receive 600,800, 1000 or 1250 mg/m2 of gemcitabine infused (after completion of romidepsin infusion) over 30 minutes on either Days 1,8 and 15 (Schedule A) or Days 1 and 15 (Schedule B) of each 28 day cycle. Subsequent doses of gemcitabine will be based on treatment-related toxicities.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically confirmed advanced solid tumors
  • measurable or evaluable disease
  • age ≥18 years
  • written informed consent
  • ECOG performance status of 0-1

Exclusion Criteria:

  • Prior treatment with romidepsin or gemcitabine
  • Prior chemotherapy treatment within 3 weeks prior to the first day of treatment or prior treatment with an investigational agent within 4 weeks prior to the first day of treatment. Patients must have recovered from all therapy-related toxicities (CTC grade ≤ 1)
  • Prior radiotherapy within 4 weeks prior to the first day of treatment. Patients who have not fully recovered or whose acute toxicity related to prior radiotherapy has not returned to baseline are ineligible.
  • Prior surgery within 3 weeks prior to the first day of treatment, excluding surgical biopsies and port placements
  • Concomitant use of any other anti-cancer therapy
  • Concomitant use of any investigational agent
  • Use of any investigational agent within 4 weeks of study entry
  • Any known cardiac abnormalities, including congenital QT syndrome, myocardial infarction, CAD, CHF, chronic hypertension:
  • Serum potassium <4.0 mmol/L or serum magnesium <2.0 mg/dL (electrolyte abnormalities can be corrected with supplementation to meet inclusion criteria)
  • Concomitant use of drugs that may cause a prolongation of the QTc
  • Concomitant use of CYP3A4 inhibitors
  • Clinically significant active infection
  • Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Inadequate bone marrow or other organ function as evidenced by:
  • Hemoglobin <9 g/dL (Transfusions and/or erythropoietin are permitted.)
  • Absolute neutrophil count (ANC) ≤1.5 x 109 cells/L
  • Platelet count <100 x 109 cells/L or platelet count <75 x 109 cells/L if bone marrow disease involvement is documented
  • Total bilirubin >2.0 x upper limit of normal (ULN)
  • Aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >2.0 x ULN or >3.0 x ULN in the presence of demonstrable liver metastases
  • Serum creatinine >2.0 x ULN
  • Patients who are pregnant or breast-feeding
  • Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379639

Locations
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Gloucester Pharmaceuticals
Investigators
Principal Investigator: Howard A. Burris, M.D. Sarah Cannon Research Institute
  More Information

No publications provided

Responsible Party: Gloucester Pharmaceuticals, Inc. ( Jean Nichols, Ph.D. )
Study ID Numbers: GPI-06-0003
Study First Received: September 20, 2006
Last Updated: September 3, 2008
ClinicalTrials.gov Identifier: NCT00379639     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Gloucester Pharmaceuticals:
Pancreatic cancer
advanced solid tumors

Study placed in the following topic categories:
Antimetabolites
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Endocrine System Diseases
Romidepsin
Antiviral Agents
Immunosuppressive Agents
Anti-Bacterial Agents
Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Romidepsin
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009