Decitabine in Treating Patients With Unresectable Lung or Esophageal Cancer or Malignant Mesothelioma of the Pleura
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ClinicalTrials.gov Identifier: NCT00019825 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : April 29, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Esophageal Cancer Lung Cancer Malignant Mesothelioma Metastatic Cancer | Drug: decitabine | Phase 1 |
OBJECTIVES:
- 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.
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |
Official Title: | Phase I Study of Decitabine Mediated Induction of Tumor Antigen and Tumor Suppressor Gene Expression in Lung Cancer Patients |
Study Start Date : | October 1999 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 6 months
Hematopoietic:
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 10 g/dL
- WBC greater than 3,500/mm^3
Hepatic:
- PT normal
- Bilirubin less than 1.5 times upper limit of normal
Renal:
- Creatinine no greater than 1.6 mg/dL OR
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
-
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
Pulmonary:
- 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
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 30 days since prior biologic therapy for the malignant tumor
Chemotherapy:
- No prior decitabine
- At least 30 days since other prior chemotherapy for the malignant tumor
Endocrine therapy:
- See Disease Characteristics
Radiotherapy:
- See Disease Characteristics
- At least 30 days since prior radiotherapy for the malignant tumor (14 days for localized radiotherapy to nontarget lesions) and recovered
Surgery:
- See Disease Characteristics

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019825
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 | |
Center for Cancer Research | |
Bethesda, Maryland, United States, 20892 |
Study Chair: | David S. Schrump, MD | NCI - Surgery Branch |
ClinicalTrials.gov Identifier: | NCT00019825 |
Obsolete Identifiers: | NCT00001824 |
Other Study ID Numbers: |
CDR0000067228 NCI-99-C-0129 NCI-T99-0012 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | April 29, 2015 |
Last Verified: | July 2004 |
recurrent non-small cell lung cancer stage II esophageal cancer stage III esophageal cancer stage IV esophageal cancer recurrent esophageal cancer extensive stage small cell lung cancer |
recurrent small cell lung cancer advanced malignant mesothelioma recurrent malignant mesothelioma stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer malignant pleural effusion |
Lung Neoplasms Esophageal Neoplasms Mesothelioma Mesothelioma, Malignant Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Head and Neck Neoplasms Digestive System Diseases |
Esophageal Diseases Gastrointestinal Diseases Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Mesothelial Pleural Neoplasms Decitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors |