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CompletedNCT00022711Updated Jul 11, 2013

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

A Phase 2 interventional study of temozolomide in Lung Cancer, sponsored by Fox Chase Cancer Center. Completed at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-11.

Sponsored by Fox Chase Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Lung Cancer

Keywords

  • recurrent small cell lung cancer
  • intermediate type small cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 7 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Fox Chase Cancer Center is the lead sponsor of 211 studies on the registry; 30 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 8 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Temozolomide

    Temozolomide 150mg/m2/day daily. Repeat cycles every 28days for maximum of six months

    Drug: temozolomide

Interventions

  • Drugtemozolomide

    150 mg/m2/day Repeat cycles every 28 days following first daily dose of each cycle until toxicity or disease progression for a maximum of six months

06

Study locations

17 sites
  • Hunterdon Regional Cancer Center
    Flemington, New Jersey 08822, United States
  • Kimball Medical Center
    Lakewood, New Jersey 08701, United States
  • South Jersey Regional Cancer Center
    Millville, New Jersey 08332, United States
  • Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
    Mount Holly, New Jersey 08060, United States
  • Riverview Medical Center - Booker Cancer Center
    Red Bank, New Jersey 07701, United States
  • Community Medical Center
    Toms River, New Jersey 08755, United States
  • St. Francis Medical Center
    Trenton, New Jersey 08629, United States
  • Bon Secours-Holy Family Health System
    Altoona, Pennsylvania 16602, United States
  • Delaware County Memorial Hospital
    Drexel Hill, Pennsylvania 19026-1186, United States
  • Pinnacle Health Hospitals
    Harrisburg, Pennsylvania 17105-8700, United States
  • Conemaugh Memorial Hospital
    Johnstown, Pennsylvania 15905, United States
  • Saint Mary Regional Center
    Langhorne, Pennsylvania 19047, United States
  • Central Montgomery Medical Center
    Lansdale, Pennsylvania 19446-1200, United States
  • Paoli Memorial Hospital
    Paoli, Pennsylvania 19301-1792, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • Pottstown Memorial Regional Cancer Center
    Pottstown, Pennsylvania 19464, United States
  • Reading Hospital and Medical Center
    Reading, Pennsylvania 19612-6052, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00022711
Lead sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Jan 2002
Primary completion
Jan 2004
Completion
Jan 2004
Last update
Jul 11, 2013

Study contacts

Corey J. Langer, MD
study chair · Fox Chase Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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