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

NCT ID: NCT00443261

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-06-30

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).

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.

Conditions

Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 (SCCHN)

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

Group Type: EXPERIMENTAL

Azacitidine

Intervention Type: DRUG

SC azacitidine

Cisplatin

Intervention Type: DRUG

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

Interventions

Azacitidine

SC azacitidine

Intervention Type: DRUG

Cisplatin

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

Intervention Type: DRUG

Other Intervention Names

5-azacitidine, Vidaza; cis-platinum, platinol

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen K. Williamson, MD

Role: STUDY_DIRECTOR

University of Kansas Medical Center

Chao H. Huang, MD

Role: STUDY_CHAIR

University of Kansas Medical Center

Locations

Kansas City VA Medical Center

Kansas City, Missouri, United States

Countries

United States

Other Identifiers

10498

Identifier Type: -

Identifier Source: org_study_id