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

NCT00443261 | Terminated Phase 1 Results DMC

• 1 other identifier: 10498
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

Squamous Cell Carcinoma

Keywords

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate the Safety and Toxicity of Azacitidine (5-azacytidine, Vidaza®) and Cisplatin Combination

  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.

  Weeks 1-12, 24, 36

Study Arms (1)

1 (SCCHN)

EXPERIMENTAL

Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Patients will receive Azacitidine and cisplatin.

Drug: Azacitidine; Drug: Cisplatin

Interventions

Azacitidine DRUG

SC azacitidine

Also known as: 5-azacitidine, Vidaza

1 (SCCHN)

Cisplatin DRUG

cisplatin 75 mg/m\^2 day 8 every 28 days

Also known as: cis-platinum, platinol

1 (SCCHN)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Head and Neck Neoplasms

Interventions

Azacitidine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Dr. Stephen Williamson
• Organization: University of Kansas Cancer Center

swilliam@kumc.edu

9139455059

Study Officials

• Stephen K. Williamson, MD

  University of Kansas Medical Center

  STUDY DIRECTOR

• Chao H. Huang, MD

  University of Kansas Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 5, 2007
• Study Start: February 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 27, 2017
• Results First Posted: February 27, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)