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A Phase II Study Of Temozolomide In The Treatment Of Patients With Metastatic Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

A Phase II Study Of Temozolomide In The Treatment Of Patients With Metastatic Non-Small Cell Lung Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Afshin Dowlati, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068336

NCT ID:

NCT00006877

Start Date:

July 2000

Completion Date:

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Ireland Cancer CenterCleveland, Ohio  44106-5065