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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
temozolomide
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent small cell lung cancer, intermediate type small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hunterdon Regional Cancer Center
  • Kimball Medical Center
  • South Jersey Regional Cancer Center
  • Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
  • Riverview Medical Center - Booker Cancer Center
  • Community Medical Center
  • St. Francis Medical Center
  • Bon Secours-Holy Family Health System
  • Delaware County Memorial Hospital
  • Pinnacle Health Hospitals
  • Conemaugh Memorial Hospital
  • Saint Mary Regional Center
  • Central Montgomery Medical Center
  • Paoli Memorial Hospital
  • Fox Chase Cancer Center
  • Pottstown Memorial Regional Cancer Center
  • Reading Hospital and Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temozolomide

Arm Description

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 10, 2001
Last Updated
July 10, 2013
Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00022711
Brief Title
Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer
Official Title
A Phase II Study of Temozolomide (SCH 52365) in the Treatment of Patients With Relapsed Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent small cell lung cancer, intermediate type small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Temozolomide
Arm Type
Experimental
Arm Description
Temozolomide 150mg/m2/day daily. Repeat cycles every 28days for maximum of six months
Intervention Type
Drug
Intervention Name(s)
temozolomide
Intervention Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corey J. Langer, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Hunterdon Regional Cancer Center
City
Flemington
State/Province
New Jersey
ZIP/Postal Code
08822
Country
United States
Facility Name
Kimball Medical Center
City
Lakewood
State/Province
New Jersey
ZIP/Postal Code
08701
Country
United States
Facility Name
South Jersey Regional Cancer Center
City
Millville
State/Province
New Jersey
ZIP/Postal Code
08332
Country
United States
Facility Name
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Riverview Medical Center - Booker Cancer Center
City
Red Bank
State/Province
New Jersey
ZIP/Postal Code
07701
Country
United States
Facility Name
Community Medical Center
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
St. Francis Medical Center
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08629
Country
United States
Facility Name
Bon Secours-Holy Family Health System
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Delaware County Memorial Hospital
City
Drexel Hill
State/Province
Pennsylvania
ZIP/Postal Code
19026-1186
Country
United States
Facility Name
Pinnacle Health Hospitals
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17105-8700
Country
United States
Facility Name
Conemaugh Memorial Hospital
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15905
Country
United States
Facility Name
Saint Mary Regional Center
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Central Montgomery Medical Center
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446-1200
Country
United States
Facility Name
Paoli Memorial Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301-1792
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Pottstown Memorial Regional Cancer Center
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19464
Country
United States
Facility Name
Reading Hospital and Medical Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19612-6052
Country
United States

12. IPD Sharing Statement

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

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