Phase 3
N=671
S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00045162 ↗Enrolled (actual)
671
Serious AEs
21.3%
Results posted
Jul 2013
Primary outcome: Primary: Overall Survival — 9.9; 9.1 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- cisplatin (Drug); etoposide (Drug); irinotecan hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
9.9; 9.1 | — |
| SECONDARY Progression-free Survival |
5.7; 5.2 | — |
| SECONDARY Confirmed and Unconfirmed Complete and Partial Responses. |
197; 190 | — |
| SECONDARY Number of Patients With a Given Type and Grade of Adverse Event. |
0; 1; 8; 8; 2; 1 | — |
Summary
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. It is not yet known whether cisplatin combined with irinotecan is more effective than cisplatin combined with etoposide in treating extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with either irinotecan or etoposide in treating patients who have extensive-stage small cell lung cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC)
- Measurable or evaluable disease by CT scan, MRI, x-ray, physical exam, or nuclear exam
- Brain metastases allowed if previously treated with radiotherapy and/or surgery and are neurologically stable (i.e., no progressing symptoms and off steroids and anticonvulsants)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST or ALT no greater than 2.5 times ULN
Renal
- Creatinine normal
- Creatinine clearance at least 50 mL/min
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- HIV negative
- No concurrent AIDS-related illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biologic therapy for SCLC
- No filgrastim (G-CSF) within 24 hours of chemotherapy
Chemotherapy
- No prior systemic chemotherapy for SCLC
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- See Disease Characteristics
- At least 21 days since prior brain radiotherapy and recovered
- No other prior radiotherapy for SCLC
Surgery
- See Disease Characteristics
- At least 21 days since prior thoracic or other major surgery and recovered
Other
- No concurrent enzyme inducing antiepileptic drugs (phenytoin, phenobarbital, oxcarboxepine, or carbamazepine)
Data sourced from ClinicalTrials.gov (NCT00045162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.