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A Phase II Study Of Temozolomide (SCH 52365) In Subjects With Brain Metastasis From Nonsmall Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Cancer

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Trial Information

A Phase II Study Of Temozolomide (SCH 52365) In Subjects With Brain Metastasis From Nonsmall Cell Lung Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Lauren E. Abrey, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069201

NCT ID:

NCT00030836

Start Date:

October 2001

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • tumors metastatic to brain
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021