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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00022711
First received: August 10, 2001
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Lung Cancer
Drug: temozolomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Temozolomide (SCH 52365) in the Treatment of Patients With Relapsed Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Enrollment: 7
Study Start Date: January 2002
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Temozolomide
Temozolomide 150mg/m2/day daily. Repeat cycles every 28days for maximum of six months
Drug: temozolomide
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022711

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

Additional Information:
No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00022711     History of Changes
Other Study ID Numbers: FCCC-01020, NCI-G01-2005
Study First Received: August 10, 2001
Last Updated: July 10, 2013
Health Authority: United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
recurrent small cell lung cancer
intermediate type small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Dacarbazine
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014