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A Phase II Study of Temozolomide (SCH 52365) in the Treatment of Patients With Relapsed Small Cell Lung Cancer


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

Thank you

Trial Information

A Phase II Study of Temozolomide (SCH 52365) in the Treatment of Patients With Relapsed Small Cell Lung Cancer


OBJECTIVES:

- Determine the efficacy of temozolomide, in terms of response rate and safety, in
patients with relapsed or progressive small cell lung cancer.

- Determine the time to progression and overall survival in patients treated with this
drug.

- Assess quality of life of patients treated with this drug.

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

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

Hepatic:

- 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

Renal:

- Creatinine no greater than 2 mg/dL

Other:

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior biologic therapy

- No concurrent immunotherapy

- No concurrent biologic therapy

- Concurrent epoetin alfa allowed

Chemotherapy:

- 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)

Radiotherapy:

- 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

Surgery:

- Not specified

Other:

- Recovered from prior therapy

- No other concurrent investigational drugs

- Concurrent pamidronate allowed

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Corey J. Langer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068844

NCT ID:

NCT00022711

Start Date:

October 2001

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent small cell lung cancer
  • intermediate type small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Community Medical CenterToms River, New Jersey  08755
St. Francis Medical CenterTrenton, New Jersey  08629
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
South Jersey Regional Cancer CenterMillville, New Jersey  08332
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington CountyMount Holly, New Jersey  08060
Hunterdon Regional Cancer CenterFlemington, New Jersey  08822
Kimball Medical CenterLakewood, New Jersey  08701
Riverview Medical Center - Booker Cancer CenterRed Bank, New Jersey  07701
Saint Mary Regional CenterLanghorne, Pennsylvania  19047
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Pinnacle Health HospitalsHarrisburg, Pennsylvania  17105-8700
Conemaugh Memorial HospitalJohnstown, Pennsylvania  15905
Pottstown Memorial Regional Cancer CenterPottstown, Pennsylvania  19464
Bon Secours-Holy Family Health SystemAltoona, Pennsylvania  16602
Central Montgomery Medical CenterLansdale, Pennsylvania  19446-1200