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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: temozolomide

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Corey J. Langer, MD, Fox Chase Cancer Center

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): January 1, 2004
• Study Completion (Actual): January 1, 2004

Study Registration Dates

• First Submitted: August 10, 2001
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): July 11, 2013
• Last Update Submitted That Met QC Criteria: July 10, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: recurrent small cell lung cancer; intermediate type small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide
• Other Study ID Numbers: FCCC-01020; NCI-G01-2005 (Other Identifier: NCI)