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Decitabine in Treating Patients With Unresectable Lung or Esophageal Cancer or Malignant Mesothelioma of the Pleura

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients who have unresectable lung or esophageal cancer or malignant mesothelioma of the pleura.

Tracking Information
First Received DateJuly 11, 2001
Last Changed DateApril 28, 2015
Start DateOctober 1999
Descriptive Information
PhasePhase 1
Study TypeInterventional
  • Esophageal Cancer
  • Lung Cancer
  • Malignant Mesothelioma
  • Metastatic Cancer
  • Drug: decitabine
Detailed Description


- Determine the pharmacokinetics, toxicity, and maximum tolerated dose of decitabine in patients with unresectable primary small cell or non-small cell lung cancer, unresectable esophageal cancer, or malignant pleural mesothelioma.

- Measure the expression of NY-ESO-1 in tissue samples of these patients before and after receiving this drug.

- Assess the serologic response to NY-ESO-1 in these patients before and after receiving this drug.

- Measure the expression of p16 tumor suppressor gene in these patients before and after receiving this drug.

OUTLINE: This is a dose-escalation study for each stratification group. Patients are stratified according to number of prior therapies (2 or fewer vs 3 or more).

Patients receive decitabine IV continuously on days 1-3. Treatment repeats every 5 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after completion of the second course receive 2 additional courses.

Cohorts of 3-6 patients receive escalating doses of decitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined for a particular stratum, additional patients from that stratum are treated at the MTD.

Patients are followed for 1 month.

PROJECTED ACCRUAL: A maximum of 72 patients (36 per stratum) will be accrued for this study.

Recruitment Information
Recruitment StatusCompleted
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility Criteria


- Histologically or cytologically confirmed unresectable primary small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC), unresectable esophageal cancer, malignant pleural mesothelioma, or pleural effusions secondary to extrathoracic malignancies

- Disease must be readily accessible to biopsy by endoscopy or percutaneous fine-needle aspiration

- Extrathoracic metastatic disease allowed if no evidence of active intracranial or leptomeningeal metastases

- Patients treated with prior resection or radiotherapy for intracranial metastatic disease may be eligible provided there is no evidence of active disease on two MRIs (taken one month apart) and patients require no anticonvulsant medications or steroids to control residual symptoms

- No limited stage SCLC or operable NSCLC



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 6 months


- Platelet count greater than 100,000/mm^3

- Hemoglobin greater than 10 g/dL

- WBC greater than 3,500/mm^3


- PT normal

- Bilirubin less than 1.5 times upper limit of normal


- Creatinine no greater than 1.6 mg/dL OR

- Creatinine clearance greater than 60 mL/min


- Any of the following conditions require clearance by a cardiologist:

- Prior coronary artery disease

- Prior transmural myocardial infarction

- Congestive heart failure

- Fixed defects on thallium scan with ejection fraction greater than 40%

- No unstable angina

- No recent deep venous thrombosis requiring anticoagulation


- FEV1 and DLCO greater than 30% of predicted

- pCO_2 less than 50 mm Hg

- pO_2 greater than 60 mm Hg on room air

- No recent pulmonary embolism requiring anticoagulation


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infection

- HIV negative


Biologic therapy:

- At least 30 days since prior biologic therapy for the malignant tumor


- No prior decitabine

- At least 30 days since other prior chemotherapy for the malignant tumor

Endocrine therapy:

- See Disease Characteristics


- See Disease Characteristics

- At least 30 days since prior radiotherapy for the malignant tumor (14 days for localized radiotherapy to nontarget lesions) and recovered


- See Disease Characteristics

Administrative Information
SponsorNational Cancer Institute (NCI)
Verification DateJuly 2004
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