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Temozolomide in Treating Patients With Metastatic Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: December 6, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006877
  Purpose

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

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have metastatic non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: temozolomide
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Temozolomide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study Of Temozolomide In The Treatment Of Patients With Metastatic Non-Small Cell Lung Cancer

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

Study Start Date: July 2000
Detailed Description:

OBJECTIVES: I. Determine the efficacy of temozolomide in terms of complete and partial response rates in patients with metastatic non-small cell lung cancer. II. Determine the safety of this regimen in these patients. III. Determine the time to progression and overall survival in patients treated with this regimen. IV. Determine the quality of life and changes in disease-related symptoms in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive oral temozolomide daily on days 1-7 and 15-21. Treatment continues every 4 weeks for a maximum of 6 months in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 4 weeks during study, and then every 8 weeks after study. Patients are followed for 1 month and then every 8 weeks thereafter.

PROJECTED ACCRUAL: A total of 15-60 patients 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 proven metastatic non-small cell lung cancer Eligible subtypes: Adenocarcinoma Squamous cell carcinoma Large cell carcinoma At least 1 bidimensionally measurable lesion, at least 2 cm by 2 cm in perpendicular diameter on radiologic study Previously irradiated bony lesions are not considered measurable unless there is evidence of disease progression at that site prior to study No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN (5 times ULN if documented liver metastases) Alkaline phosphatase no greater than 2 times ULN (5 times ULN if documented liver metastases) Renal: Blood urea nitrogen no greater than 1.5 times ULN Creatinine no greater than 1.5 times ULN Other: No active nonmalignant systemic disease that would increase risk No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction) No other malignancy within the past 5 years except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer HIV negative No AIDS-related illness Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy or biologic therapy No concurrent growth factors or epoetin alfa Chemotherapy:

At least 4 weeks since prior chemotherapy No more than 1 prior chemotherapy regimen for metastatic disease No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radiotherapy for local control or as palliative therapy for a painful bony lesion allowed No prior radiotherapy to 50% or more of bone marrow At least 4 weeks since prior radiotherapy to 15% or more of bone marrow (2 weeks for radiotherapy to less than 15% of bone marrow) and recovered No concurrent radiotherapy Surgery: Not specified Other: Recovered from any prior therapy No other concurrent investigational drugs

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006877

Locations
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Ireland Cancer Center
Investigators
Study Chair: Afshin Dowlati, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068336, CWRU-SCH-1500, CWRU-050002, SPRI-P00349, NCI-G00-1876
Study First Received: December 6, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006877     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung

Study placed in the following topic categories:
Thoracic Neoplasms
Temozolomide
Recurrence
Carcinoma
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Adenocarcinoma of Lung
Antineoplastic Agents, Alkylating
Adenocarcinoma
Alkylating Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Temozolomide
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009