Clinical trial · Interventional
Irinotecan and Carboplatin as First-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
A Phase II Trial of Carboplatin and Irinotecan (CPT-11) as First-Line Therapy for Patients With Extensive Stage Small Cell Lung Cancer
- 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: The general results of combining irinotecan and platin-based chemotherapies have been very encouraging. As the toxicity profile associated with carboplatin is preferable over cisplatin it is our expectation that patients and physicians would prefer to use this combination if it is equally or more efficacious. To date there has been no agreement regarding the optimal combination of these agents. Based on the trials described in the protocol and our experience with carboplatin/irinotecan in the treatment of non-small cell lung cancer the present trial will utilize a 21-day cycle of irinotecan 50 mg/m2 given on days 1 and 8 and carboplatin AUC 5 (based on the Calvert formula) on day 1. PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works as first-line therapy in treating patients with extensive-stage 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 |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Therapeutic Intervention
- description
- Lung cancer patients will be treated for four 3-week cycles (12 weeks) in the absence of progressive disease, unacceptable toxicity, or withdrawal of patient consent. Up to two additional cycles may be administered at the discretion of the treating physician. If at treatment withdrawal the disease has responded or is stable, the patient will continue to be followed for efficacy (i.e. until progressive disease)at 8 week intervals. Following the diagnosis of progressive disease, patients will be followed every two months for survival.
- interventionNames
- Drug: Carboplatin
- Drug: irinotecan hydrochloride
Primary outcomes (1)
- measure
- Patient Response
- timeFrame
- 1.66 months (average duration, on treatment date to best response date)
- description
- Patient response to treatment: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically or cytologically confirmed small cell lung cancer (SCLC)
* Extensive stage small cell lung cancer
* Must have ≥ 1 unidimensionally measurable lesion (longest diameter to be recorded) ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
* Lesion cannot be from a previously irradiated area
* Lesions that are considered nonmeasurable include the following:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Lymphangitis cutis/pulmonis
* Abdominal masses not confirmed and followed by imaging techniques
* Cystic lesions
* Tumor lesions in a previously irradiated area
* No brain metastasis or carcinomatous meningitis unless stable and asymptomatic
PATIENT CHARACTERISTICS
* ECOG performance status 0-2
* Life expectancy ≥ 3 months
* ANC ≥ 1,500/mm³
* Platelet count \> 100,000/mm³
* Serum bilirubin ≤ 1.5 mg/dL
* AST/SGOT ≤ 2.5 times upper limit of normal (ULN) (or ≤ 5 times ULN if liver metastases present)
* Serum creatinine ≤ 2.0 mg/dl
* Hemoglobin ≥ 9.0 g/dl
Exclusion Criteria:
* CNS metastasis excluded unless: stable and asymptomatic
* Coexisting medical condition that would preclude study compliance
* Patients with Gilbert's disease
* Uncontrolled diabetes mellitus, defined as random blood sugar ≥ 300 mg/dl or \> 16.6 mmol/L
* Patients who do not discontinue phenytoin, phenobarbitol, carbamazipine, or other enzyme-inducing anticonvulsant drugs at least 7 days prior to first treatment dose on study. Gabapentin is permitted
* Patients who do not discontinue St. John's Wort prior to first treatment dose on study.
* Patients who are pregnant or breast feeding
* Concomitant second active malignancy except for any in situ cancer or adequately treated basal cell or squamous cell skin cancer or any cancer from which the patients has been disease-free for at least 2 years
* No administration of any prior systemic anticancer therapy for extensive stage SCLC such as: chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or other experimental agents. Concurrent use of other anticancer therapy including inhibitors of vascular endothelial or epidermal growth factor pathways is prohibited. Prior radiation is allowed
* Symptomatic brain metastasis or carcinomatous meningitis
PRIOR CONCURRENT THERAPY:References
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