Clinical Trial: Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer

This study has been completed.

Sponsors and Collaborators: Fox Chase Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)


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 relapsed or progressive small cell lung cancer.

Condition Treatment or Intervention Phase
Recurrent Small Cell Lung Cancer
intermediate type small cell lung cancer
 Drug: temozolomide
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lung Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Temozolomide in Patients With Relapsed or Progressive Small Cell Lung Cancer

Further Study Details: 


OUTLINE: This is a multicenter study. Patients are stratified according to response to prior chemotherapy (chemosensitive at least 60 days after prior therapy vs chemoresistant less than 60 days after or progression during prior therapy).

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.

Quality of life is assessed prior to each course of chemotherapy, at 30 days after study completion, and then every 8 weeks thereafter.

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

PROJECTED ACCRUAL: A total of 37-79 patients (14-33 chemosensitive and 23-46 chemoresistant) will be accrued for this study.


Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both



  • Histologically or cytologically confirmed relapsed or progressive small cell lung cancer
  • Classical or intermediate variant OR
  • Relapsed or progressive extrapulmonary small cell carcinoma of unknown origin
  • Bidimensionally measurable disease
  • At least 1 cm by 1 cm by physical exam or radiologic exam
  • Outside prior radiation port unless clinical evidence of disease progression
  • Previously radiated brain metastases allowed provided stable or improved


  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 12 weeks


  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3


  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • SGOT/SGPT no greater than 3 times ULN (5 times ULN if liver metastases present)
  • Alkaline phosphatase no greater than 5 times ULN


  • Creatinine no greater than 2 mg/dL


  • HIV negative
  • No AIDS-related illness
  • No frequent vomiting or medical condition that would interfere with oral medication administration (e.g., partial bowel obstruction)
  • No active nonmalignant systemic disease that would preclude study
  • No other active invasive malignancy within the past year or concurrently requiring ongoing treatment
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for at least 1 month before, during, and for at least 3 months after study


  • At least 4 weeks since prior biologic therapy
  • No concurrent immunotherapy
  • No concurrent biologic therapy
  • Concurrent epoetin alfa allowed


  • At least 4 weeks since prior chemotherapy
  • No more than 1 prior continuous or discontinuous chemotherapy regimen for metastatic disease
  • No other concurrent chemotherapy

Endocrine therapy:

  • Concurrent hormonal therapy to boost appetite allowed (e.g., corticosteroids or medroxyprogesterone)


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy to 15% or more of bone marrow
  • At least 1 week since prior radiotherapy to less than 15% of bone marrow
  • No prior radiotherapy to 50% or more of bone marrow
  • No concurrent radiotherapy


  • Not specified


Location Information

New Jersey
      Community Medical Center, Toms River,  New Jersey,  08755,  United States

      Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County, Mount Holly,  New Jersey,  08060,  United States

      Hunterdon Regional Cancer Center, Flemington,  New Jersey,  08822,  United States

      Kimball Medical Center, Lakewood,  New Jersey,  08701,  United States

      Riverview Medical Center - Booker Cancer Center, Red Bank,  New Jersey,  07701,  United States

      South Jersey Regional Cancer Center, Millville,  New Jersey,  08332,  United States

      St. Francis Medical Center, Trenton,  New Jersey,  08629,  United States

      Bon Secours-Holy Family Health System, Altoona,  Pennsylvania,  16602,  United States

      Central Montgomery Medical Center, Lansdale,  Pennsylvania,  19446-1200,  United States

      Conemaugh Memorial Hospital, Johnstown,  Pennsylvania,  15905,  United States

      Delaware County Memorial Hospital, Drexel Hill,  Pennsylvania,  19026-1186,  United States

      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States

      Paoli Memorial Hospital, Paoli,  Pennsylvania,  19301-1792,  United States

      Pinnacle Health Hospitals, Harrisburg,  Pennsylvania,  17105-8700,  United States

      Pottstown Memorial Regional Cancer Center, Pottstown,  Pennsylvania,  19464,  United States

      Reading Hospital and Medical Center, Reading,  Pennsylvania,  19612-6052,  United States

      Saint Mary Regional Center, Langhorne,  Pennsylvania,  19047,  United States

Study chairs or principal investigators

Corey Jay Langer, MD,  Study Chair,  Fox Chase Cancer Center   

More Information

Study ID Numbers:  CDR0000068844; FCCC-01020; SPRI-H-P00740; NCI-G01-2005
Record last reviewed:  February 2005
Last Updated:  February 17, 2005
Record first received:  August 10, 2001 Identifier:  NCT00022711
Health Authority: Unspecified processed this record on 2005-04-08

Cache Date: April 9, 2005