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Radiation Therapy With or Without Temozolomide in Treating Patients With Non-Small Cell Lung Cancer That is Metastatic to the Brain
This study is ongoing, but not recruiting participants.
First Received: February 14, 2002   Last Updated: August 29, 2009   History of Changes
Sponsor: Memorial Sloan-Kettering Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00030836
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of radiation therapy plus temozolomide to that of radiation therapy alone in treating patients who have non-small cell lung cancer that is metastatic to the brain.


Condition Intervention Phase
Metastatic Cancer
Drug: temozolomide
Radiation: radiation therapy
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control
Official Title: A Phase II Study Of Temozolomide (SCH 52365) In Subjects With Brain Metastasis From Nonsmall Cell Lung Cancer

Resource links provided by NLM:


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

Study Start Date: October 2001
Detailed Description:

OBJECTIVES:

  • Compare the time to symptomatic neurologic progression, in terms of worsening in 1 or more of 6 clinical categories including headaches, focal weakness, mentation and/or communication, visual changes, coordination, and new cranial neuropathy, in patients with brain metastases from non-small cell lung cancer treated with whole brain radiotherapy with or without temozolomide.
  • Compare the time to progression in patients treated with these regimens.
  • Compare the overall response rate and overall survival in patients treated with these regimens.
  • Compare changes in disease-related symptoms in patients treated with these regimens.
  • Compare the effect of these regimens on steroid usage and seizure frequency in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior chemotherapy (yes vs no) and recursive partitioning analysis classification (1 vs 2). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive whole brain radiotherapy once daily 5 days a week for 2 weeks beginning on day 1.
  • Arm II: Patients receive oral placebo and radiotherapy as in arm I. Quality of life is assessed on day 1 of each course, on day 30 after the last course, and then every 8 weeks until disease progression.

Patients are followed at 30 days and then every 8 weeks thereafter.

PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) 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 confirmed non-small cell lung cancer

    • Squamous cell carcinoma
    • Adenocarcinoma (including large cell carcinoma)
    • Non-small cell cancer not otherwise specified
  • Brain metastases

    • Biopsy not required
    • Ineligible for surgical resection or radiosurgery
  • Systemic disease that is not in immediate need of chemotherapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • 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 liver metastases present)
  • Alkaline phosphatase no greater than 2 times ULN (5 times ULN if liver metastases present)

Renal:

  • BUN no greater than 1.5 times ULN
  • Creatinine no greater than 1.5 times ULN

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known HIV positivity or AIDS-related illness
  • No active nonmalignant systemic disease
  • No frequent vomiting or other medical condition that would preclude oral medication intake (e.g., partial bowel obstruction)
  • No other prior or concurrent malignancies within the past 5 years except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy or biologic therapy except growth factors

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy and recovered
  • No more than 1 prior chemotherapy regimen for systemic metastatic disease
  • No prior chemotherapy for brain metastases
  • No prior temozolomide
  • Concurrent chemotherapy (docetaxel, paclitaxel, or cisplatin) to alleviate progressing systemic disease is allowed

Endocrine therapy:

  • Concurrent dexamethasone required

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy to 15% or more of total bone marrow (2 weeks for less than 15% of bone marrow) and recovered
  • No prior radiotherapy to 50% or more of total bone marrow
  • No prior radiotherapy to the brain
  • Prior radiotherapy for local control or palliative therapy for a painful bony lesion allowed
  • Concurrent radiotherapy to painful bony lesions allowed if no more than 15% of bone marrow is irradiated

Surgery:

  • See Disease Characteristics
  • Prior surgery for brain metastases allowed

Other:

  • No other concurrent investigational drugs
  • Recovered from toxic effects of all prior therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030836

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Lauren E. Abrey, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069201, MSKCC-01133, SPRI-P02143, NCI-G01-2048
Study First Received: February 14, 2002
Last Updated: August 29, 2009
ClinicalTrials.gov Identifier: NCT00030836     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
tumors metastatic to brain

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
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Neoplasm Metastasis
Antineoplastic Agents, Alkylating
Alkylating Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009