Clinical trial · Interventional
Irinotecan and Gemcitabine in Treating Patients With Recurrent or Progressive Stage III or Stage IV Non-Small Cell Lung Cancer
Phase II Study of Irinotecan Followed by Gemcitabine in NSCLC Following Failure of Platinum Based Therapy
- 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, such as irinotecan and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Irinotecan may also increase the effectiveness of gemcitabine. Giving irinotecan together with gemcitabine may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with gemcitabine works in treating patients with recurrent or progressive stage III or stage IV 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 |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective response (complete, partial, and stable disease)
Secondary outcomes (1)
- measure
- Median time to progression
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), meeting 1 of the following stage criteria:
* Stage IIIA or IIIB disease
* Progressive disease
* Stage IV disease
* Failed 1 prior platinum-based chemotherapy regimen, including adjuvant therapy
* Measurable or evaluable disease, as defined by 1 of the following criteria:
* At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR \> 10 mm by spiral CT scan
* Lesions apparent on CT scan that do not meet the criterion for measurability
* Brain metastases allowed provided patient has received definitive therapy for metastases, is asymptomatic, and has extra-CNS metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* More than 12 weeks
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* AST and ALT ≤ 1.5 times normal
* Alkaline phosphatase \< 1.5 times normal
* Bilirubin ≤ 1.3 mg/dL
Renal
* Creatinine ≤ 1.6 mg/dL OR
* Creatinine clearance ≥ 50 mL/min
Cardiovascular
* No unstable angina
* No congestive heart failure
* No myocardial infarction within the past 3 months
* No life-threatening ventricular arrhythmia requiring maintenance therapy
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
* No uncontrolled seizure disorder
* No uncontrolled diabetes mellitus
* No active infection requiring systemic therapy
* No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No other unstable or serious condition
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy
* Prior irinotecan allowed
* No prior gemcitabine
* No more than 1 prior chemotherapy regimen for NSCLC, excluding gefitinib
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery
* Not specified
Other
* More than 1 month since prior participation in another clinical trial using an investigational agent
* No other concurrent investigational agentsReferences
Publications (1)
- RESULTRamnath N, Yu J, Khushalani NI, Gottlieb RH, Schwarz JK, Iyer RV, Rustum YM, Creaven PJ. Scheduled administration of low dose irinotecan before gemcitabine in the second line therapy of non-small cell lung cancer: a phase II study. Anticancer Drugs. 2008 Aug;19(7):749-52. doi: 10.1097/CAD.0b013e328301c54f. PMID 18594219