Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer
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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 2 |
| 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:
- 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.
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
- 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
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
Additional Information:
No publications provided
| 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 |
Keywords provided by National Cancer Institute (NCI):
|
recurrent small cell lung cancer intermediate type small cell lung cancer |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on June 18, 2013