Clinical trial · Interventional
Topotecan and Paclitaxel in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer
Phase II Trial of Topotecan and Paclitaxel in Previously Treated Patients With Relapsed Small Cell Lung Cancer
NCT00003281CI-TRIAL-00023025completedPhase 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of topotecan and paclitaxel in treating patients who have recurrent or refractory 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- topotecan + paclitaxel + radiotherapy
- description
- Patients receive topotecan IV over 30 minutes on days 1-3 and paclitaxel IV over 3 hours on day 3. Courses repeat every 4 weeks. Patients who achieve partial response or stable disease continue treatment in the absence of complete response or disease progression. Patients who develop disease progression in the CNS only should receive whole brain radiotherapy and then continue treatment. Patients who achieve complete remission receive a maximum of 6 courses of treatment. Patients may then undergo prophylactic cranial irradiation and/or thoracic radiotherapy at the discretion at the attending physician. Patients are followed every 3 months for 2 years and then at 3 years after study.
- interventionNames
- Drug: paclitaxel
- Drug: topotecan hydrochloride
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- response rate
- timeFrame
- Up to 5 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Stratum A (less than 3 months since prior therapy) closed to accrual effective 06/20/2000) * Histologically or cytologically confirmed recurrent or refractory small cell lung cancer * Only 1 prior regimen allowed (an alternating regimen with cyclophosphamide/doxorubicin/vincristine and etoposide/cisplatin is acceptable) * No mixed histology * Measurable or evaluable disease that has not been in the field of prior radiotherapy * No uncontrolled CNS metastases (treated CNS metastases eligible) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Hematopoietic: * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR * Direct bilirubin normal Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No unstable angina pectoris * No uncontrolled congestive heart failure * No myocardial infarction within the past 3 months Other: * No uncontrolled infections * No other concurrent malignancy except skin cancer or localized prostate cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No prior topoisomerase I inhibitor (e.g., topotecan or irinotecan) or taxane (e.g., paclitaxel or docetaxel) * At least 3 months since other prior chemotherapy Radiotherapy: * See Disease Characteristics * At least 2 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * At least 3 weeks since any prior major surgery
References
Publications (1)
- RESULTDy GK, Jett JR, Geoffroy FJ, Krewer KD, Tazelaar H, Maurer M, Rowland K, Mailliard J, Krook J, Dakhil S, Kutteh L, Kugler J, Wender D. Topotecan and paclitaxel in previously treated patients with relapsed small cell lung cancer: phase II trial of the North Central Cancer Treatment Group. J Thorac Oncol. 2006 Mar;1(3):211-7. doi: 10.1016/s1556-0864(15)31570-7. No abstract available. PMID 17409859