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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00019825
First received: July 11, 2001
Last updated: December 13, 2008
Last verified: July 2004
  Purpose

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 Intervention Phase
Esophageal Cancer
Lung Cancer
Malignant Mesothelioma
Metastatic Cancer
Drug: decitabine
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of Decitabine Mediated Induction of Tumor Antigen and Tumor Suppressor Gene Expression in Lung Cancer Patients

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 1999
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019825

Locations
United States, Maryland
Center for Cancer Research
Bethesda, Maryland, United States, 20892
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Study Chair: David S. Schrump, MD NCI - Surgery Branch
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00019825     History of Changes
Obsolete Identifiers: NCT00001824
Other Study ID Numbers: CDR0000067228, NCI-99-C-0129, NCI-T99-0012
Study First Received: July 11, 2001
Last Updated: December 13, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Esophageal Neoplasms
Lung Neoplasms
Mesothelioma
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Neoplastic Processes
Pathologic Processes
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 13, 2014