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| Sponsor: | Fox Chase Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00022711 |
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 II |
| Study Type: | Interventional |
| Study Design: | 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 |
| Study Start Date: | October 2001 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed relapsed or progressive small cell lung cancer
Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and 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 | |
| Study Chair: | Corey J. Langer, MD | Fox Chase Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00022711 History of Changes |
| Other Study ID Numbers: | CDR0000068844, FCCC-01020, SPRI-H-P00740, NCI-G01-2005 |
| Study First Received: | August 10, 2001 |
| Last Updated: | October 12, 2008 |
| Health Authority: | United States: Federal Government |
|
recurrent small cell lung cancer intermediate type small cell lung cancer |
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic |
Bronchial Neoplasms Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |