Azacitidine and Cisplatin in Patients With Advanced Lung or Head and Neck Cancer

NCT00901537 | Terminated Phase 1

• 2 other identifiers: 58358IND 105076 (IND Exempt)
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The standard of care for head and neck and lung cancer includes chemotherapy, radiation and surgery. For patients with cancer of head and neck or lung that recurs after surgery and/or radiation, or has spread to other parts of body, chemotherapy using cisplatin can slow down tumor growth and extend lifespan. The study drug, azacitidine, can block the ability of some cancer cells to replicate, and has been approved by the Food and Drug Administration for use in myelodysplastic syndrome, which is a slowly developing blood cell-related cancer. In laboratory and animal experiments using head and neck and lung cancer cells, azacitidine has been shown to be a cisplatin "helper", (that is, it makes cisplatin more effective in stopping the growth of head and neck and lung cancer. ) Since the combination of azacitidine and cisplatin has not been used in patients with head and neck or lung cancer, the investigators are performing this study combining azacitidine and cisplatin to find out what effects, good and/or bad, the study drug may have on patients with advanced head and neck or lung cancer. The investigators are doing this study because they would like to find a better treatment for these types of cancer.

Conditions

Non-small Cell Lung Cancer; Squamous Cell Carcinoma of the Head and Neck

Keywords

Non-small Cell Lung Cancer; Head and Neck Cancer; Azacitidine; Vidaza; Cisplatin

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety and toxicity of azacitidine and cisplatin combination.

  weekly for first 4 weeks, then weekly times 2 for every 4 weeks

Secondary Outcomes (1)

• Determine the biologically effective dose of azacitidine, maximum tolerated dose of azacitidine and cisplatin combination, and tumor response

  every 8 weeks for response evaluation

Study Arms (1)

Azacitidine and Cisplatin

EXPERIMENTAL

Every 4 weeks, azacitidine is given daily as subcutaneous injection for 5 days from day 1 to day 5, and cisplatin is given as intravenous injection on day 8. The dose of azacitidine will be dose escalated among each group of 3-6 patients, and the dose of cisplatin is fixed.

Drug: Azacitidine and Cisplatin

Interventions

Azacitidine and Cisplatin DRUG

We plan to give azacitidine daily as subcutaneous injection at escalated doses (37, 60, 75, 85, 100 and 110 mg/m2) for 5 days from day 1 to day 5, and give cisplatin 75 mg/m2 as intravenous injection on day 8, every 4 weeks as a cycle.

Also known as: Vidaza, 5-Azacytidine

Azacitidine and Cisplatin

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 squamous cell carcinoma of head and neck or non-small cell lung cancer 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, bevacizumab or erlotinib) 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. Patients who have received prior treatment with EGFR inhibitor alone such as cetuximab or erlotinib are allowed to enter the study at least 14 days after receiving the last dose of the prior treatment.
• 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 28 days before entry into the study and all complications/adverse events must have been resolved.
• Age \>18 years.
• ECOG performance status \<2 (Karnofsky \>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 (i.e. radiation, chemotherapy, immunotherapy, biological therapy or gene therapy) while they are on this study.
• Patients must be able to understand and sign a written informed consent document approved for this trial.
• Women of childbearing potential must have a negative serum pregnancy test prior to azacitidine treatment.

You may not qualify if:

• Patients with symptomatic brain metastases are excluded from this clinical trial. Patients with asymptomatic brain metastases are allowed. The patient must be stable for 2 weeks after radiotherapy; if the patient is on corticosteroids, the dose of cortico steroids must have been stable for 2 weeks prior to first dose of study treatment, or be in the process of being tapered.
• 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

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Cancer Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

Azacitidine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

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

Study Officials

• Chung-Tsen Hsueh, MD, PhD

  Loma Linda University Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: May 12, 2009
• First Posted: May 14, 2009
• Study Start: February 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

US (1)