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

Information source: University of Kansas
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Squamous Cell Carcinoma

Intervention: Azacitidine (Drug); Cisplatin (Drug)

Phase: Phase 1

Status: Terminated

Sponsored by: University of Kansas

Official(s) and/or principal investigator(s):
Stephen K. Williamson, MD, Principal Investigator, Affiliation: University of Kansas
Chao H. Huang, MD, Principal Investigator, Affiliation: University of Kansas

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).

Clinical Details

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

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

Secondary outcome: 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

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Kansas City VA Medical Center, Kansas City, Missouri 64128, United States
Additional Information

Starting date: February 2007
Last updated: October 6, 2011

Page last updated: August 23, 2015

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