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Azacitidine and Cisplatin for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

This study has been terminated.
(Accrual problems)
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT00443261
First received: March 2, 2007
Last updated: January 8, 2017
Last verified: January 2017
  Purpose
To evaluate the safety and toxicity of azacitidine (5-azacitidine, Vidaza®) and cisplatin combination in patients with squamous cell carcinoma of head and neck (SCCHN).

Condition Intervention Phase
Squamous Cell Carcinoma Drug: Azacitidine Drug: Cisplatin Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Azacitidine in Combination With Cisplatin Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • Evaluate the Safety and Toxicity of Azacitidine (5-azacytidine, Vidaza®) and Cisplatin Combination [ Time Frame: Weeks 1-12, 24, 36 ]
    Although response is not the primary endpoint of this trial, patients with measurable disease will by assessed by standard criteria. For the purpose of this study, patients should be re-evaluated every 8 weeks by imaging study. In addition to baseline scan, confirmatory scans will also be obtained 4 weeks following initial documentation of an objective response.


Enrollment: 1
Study Start Date: February 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 (SCCHN)
Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Patients will receive Azacitidine and cisplatin.
Drug: Azacitidine
SC azacitidine
Other Name: 5-azacitidine, Vidaza
Drug: Cisplatin
cisplatin 75 mg/m^2 day 8 every 28 days
Other Name: cis-platinum, platinol

Detailed Description:
Open-label, non-randomized and dose escalation study in which groups of 3-6 patients with squamous cell carcinoma of the head and neck will receive sequentially increased dosages of azacitidine SC injection in combination with a fixed dose of cisplatin IV injection until dose-limiting toxicity is demonstrated in 2 of the 6 patients.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically proven SCCHN that is either metastatic or has persisted or recurred following definitive surgery and/or radiation therapy, and is not amenable to salvage surgical resection.
  • Patients may have received previous chemotherapy and/or biological treatment (such as cetuximab) for the recurrent or metastatic disease. Prior treatment must have been completed at least 28 days (42 days for nitrosoureas or mitomycin C) prior to entering the study and all toxicities must have been resolved.
  • Prior radiation must have been completed at least 28 days before entry into the study and all toxicities must have been resolved (no more than 3000 cGy to fields including substantial marrow).
  • Surgery must have been completed at least 28 days before entry into the study and all complications/adverse events must have been resolved.
  • Patients must have at least one lesion amenable to serial biopsy.
  • Age greater than 18 years.
  • ECOG performance status less than 2 (Karnofsky greater than 60%).
  • Life expectancy of greater than 3 months.
  • Patients must have normal organ and marrow function
  • Patients must not be planning to receive any other concurrent therapy (ie, radiation, chemotherapy, immunotherapy, biological therapy or gene therapy) for SCCHN while they are on this study.
  • Women of childbearing potential must have a negative serum pregnancy test prior to azacitidine treatment.

Exclusion Criteria:

  • Patients must not be planning to receive any other concurrent therapy (ie, radiation, chemotherapy, immunotherapy, biological therapy, investigational agents or gene therapy) for SCCHN while they are on this study.
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to azacitidine, cisplatin and mannitol or other agents used in study.
  • Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
  • 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.
  • Patients known to be HIV-positive are not eligible because of the potential to confound this study's endpoints.
  • No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443261

Locations
United States, Missouri
Kansas City VA Medical Center
Kansas City, Missouri, United States, 64128
Sponsors and Collaborators
University of Kansas Medical Center
Celgene Corporation
Investigators
Study Director: Stephen K. Williamson, MD University of Kansas Medical Center
Study Chair: Chao H. Huang, MD University of Kansas Medical Center
  More Information

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00443261     History of Changes
Other Study ID Numbers: 10498
Study First Received: March 2, 2007
Results First Received: January 8, 2016
Last Updated: January 8, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Kansas Medical Center:
Head and Neck Cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cisplatin
Azacitidine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 23, 2017