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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022711
• Other study ID #: FCCC-01020
• Secondary ID: NCI-G01-2005
• Status: Completed
• Phase: Phase 2
• First received: August 10, 2001
• Last updated: July 10, 2013
• Start date: January 2002
• Est. completion date: January 2004

Study information

• Verified date: July 2013
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

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

Locations

Country	Name	City	State
United States	Bon Secours-Holy Family Health System	Altoona	Pennsylvania
United States	Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	Hunterdon Regional Cancer Center	Flemington	New Jersey
United States	Pinnacle Health Hospitals	Harrisburg	Pennsylvania
United States	Conemaugh Memorial Hospital	Johnstown	Pennsylvania
United States	Kimball Medical Center	Lakewood	New Jersey
United States	Saint Mary Regional Center	Langhorne	Pennsylvania
United States	Central Montgomery Medical Center	Lansdale	Pennsylvania
United States	South Jersey Regional Cancer Center	Millville	New Jersey
United States	Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County	Mount Holly	New Jersey
United States	Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Pottstown Memorial Regional Cancer Center	Pottstown	Pennsylvania
United States	Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Riverview Medical Center - Booker Cancer Center	Red Bank	New Jersey
United States	Community Medical Center	Toms River	New Jersey
United States	St. Francis Medical Center	Trenton	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,