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

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ClinicalTrials.gov Identifier: NCT00443261
Recruitment Status : Terminated (Accrual problems)
First Posted : March 5, 2007
Results First Posted : February 27, 2017
Last Update Posted : February 27, 2017
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Squamous Cell Carcinoma Drug: Azacitidine Drug: Cisplatin Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

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): NCT00443261


Locations
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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
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Study Director: Stephen K. Williamson, MD University of Kansas Medical Center
Study Chair: Chao H. Huang, MD University of Kansas Medical Center
More Information
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00443261    
Other Study ID Numbers: 10498
First Posted: March 5, 2007    Key Record Dates
Results First Posted: February 27, 2017
Last Update Posted: February 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Kansas Medical Center:
Head and Neck Cancer
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
 Neoplasms by Site
Azacitidine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors