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

NCT ID: NCT00022711

Last Updated: 2013-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2004-01-31

Brief 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.

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Temozolomide

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

Group Type: EXPERIMENTAL

temozolomide

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corey J. Langer, MD

Role: STUDY_CHAIR

Fox Chase Cancer Center

Locations

Hunterdon Regional Cancer Center

Flemington, New Jersey, United States

Kimball Medical Center

Lakewood, New Jersey, 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

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, United States

Bon Secours-Holy Family Health System

Altoona, Pennsylvania, United States

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, United States

Pinnacle Health Hospitals

Harrisburg, Pennsylvania, United States

Conemaugh Memorial Hospital

Johnstown, Pennsylvania, United States

Saint Mary Regional Center

Langhorne, Pennsylvania, United States

Central Montgomery Medical Center

Lansdale, Pennsylvania, 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

Countries

United States

Other Identifiers

NCI-G01-2005

Identifier Type: OTHER

Identifier Source: secondary_id

FCCC-01020

Identifier Type: -

Identifier Source: org_study_id