Clinical trial · Interventional
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
NCT00022711CI-TRIAL-00011319completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Temozolomide
- description
- Temozolomide 150mg/m2/day daily. Repeat cycles every 28days for maximum of six months
- interventionNames
- Drug: temozolomide
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.