Clinical trial · Interventional
Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer
A Phase II Study of Irinotecan (CPT-11) and Docetaxel (Taxotere) in Patients With Recurrent Non-Small Cell Lung Cancer
NCT00003900CI-TRIAL-00022893completedPhase 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 combining irinotecan and docetaxel in treating patients who have recurrent or metastatic non-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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- irinotecan + docetaxel
- description
- Patients receive irinotecan IV over 90 minutes immediately followed by docetaxel IV over 60 minutes on day 1. Treatment is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years or until death.
- interventionNames
- Drug: docetaxel
- Drug: irinotecan hydrochloride
Primary outcomes (1)
- measure
- response rate
- timeFrame
- Up to 5 years
Secondary outcomes (1)
- measure
- overall survival
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Reconfirmation of NSCLC required only if complete response for greater than 1 year Measurable or evaluable disease Tumor shrinkage or stability for at least 4 weeks on initial chemotherapy CNS metastases allowed, if symptoms controlled for greater than 8 weeks after surgery or radiotherapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-1 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 2.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease Other: No active infection At least 5 years since any other prior malignancy except curatively treated basal or squamous cell skin cancer, carcinoma in situ, or other cancers No grade 2 or worse peripheral neuropathy No uncontrolled diabetes mellitus No other serious underlying disease Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No greater than 1 prior NSCLC chemotherapy regimen, excluding low dose cisplatin as a radiosensitizer No prior irinotecan or docetaxel At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No prior radiotherapy to greater than 25% of bone marrow Surgery: See Disease Characteristics Other: No concurrent phenytoin, phenobarbital, or other anticonvulsants
References
Publications (1)
- RESULTMolina JR, Nikcevich D, Hillman S, Geyer S, Drevyanko T, Jett J, Verdirame J, Tazelaar H, Rowland K, Wos E, Kutteh L, Nair S, Fitch T, Flynn P, Stella P, Adjei AA. A Phase II NCCTG study of irinotecan and docetaxel in previously treated patients with non-small cell lung cancer. Cancer Invest. 2006 Jun-Jul;24(4):382-9. doi: 10.1080/07357900600705318. PMID 16777690