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


Phase 1
18 Years
N/A
Not Enrolling
Both
Squamous Cell Carcinoma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evaluate the safety and toxicity of azacitidine (5-azacytidine, Vidaza®) and cisplatin combination in patients with squamous cell carcinoma of head and neck (SCCHN)

Outcome Time Frame:

Weeks 1-12, 24, 36

Safety Issue:

Yes

Principal Investigator

Stephen K. Williamson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Institutional Review Board

Study ID:

10498

NCT ID:

NCT00443261

Start Date:

February 2007

Completion Date:

June 2008

Related Keywords:

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

Name

Location

Kansas City VA Medical CenterKansas City, Missouri  64128