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

Squamous Cell Carcinoma Clinical Trial

Official title:

Phase I Study of Azacitidine in Combination With Cisplatin Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00443261
• Other study ID #: 10498
• Status: Terminated
• Phase: Phase 1
• First received: March 2, 2007
• Last updated: October 6, 2011
• Start date: February 2007
• Est. completion date: June 2008

Study information

• Verified date: October 2011
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Squamous Cell Carcinoma

Intervention

Drug:
• Azacitidine
SC azacitidine
• Cisplatin
cisplatin 75 mg/m2 day 8 every 28 days

Locations

Country	Name	City	State
United States	Kansas City VA Medical Center	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety and toxicity of azacitidine (5-azacytidine, Vidaza®) and cisplatin combination in patients with squamous cell carcinoma of head and neck (SCCHN)		Weeks 1-12, 24, 36	Yes
Secondary	Determine the biologically effective dose (BED) of azacitidine by molecular analysis of tumor biopsy and peripheral blood mononuclear cells and maximum tolerated dose (MTD) of this combination regimen		Week 1-12, 24, 36	Yes