Phase 2
N=140
Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Extensive Stage Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00057837 ↗Enrolled (actual)
140
Serious AEs
72.3%
Results posted
Feb 2013
Primary outcome: Primary: Proportion of Patients With Objective Response by Solid Tumor Response Criteria (RECIST) — 0.697; 0.576 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- G-CSF (Biological); Cisplatin (Drug); Etoposide (Drug); Irinotecan (Drug); Topotecan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eastern Cooperative Oncology Group
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Objective Response by Solid Tumor Response Criteria (RECIST) |
0.697; 0.576 | — |
| SECONDARY Duration of Response |
6.0; 6.0 | — |
| SECONDARY Overall Survival |
11.9; 11.0 | — |
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 which combination chemotherapy regimen is more effective in treating extensive-stage small cell lung cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer.
Eligibility Criteria
INCLUSION CRITERIA
- Extensive stage small cell lung cancer (SCLC) with measurable disease, evaluated within 2 weeks prior to randomization
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- Disease-free for >=5 years if had a prior second malignancy other than treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
- Adequate hematologic, hepatic and renal function determined by the following tests, within 4 weeks prior to randomization: white blood cell (WBC) >=4000/mm3 and platelets >=100,000/mm3; bilirubin =30 using the formulas in the protocol
- Age 18 and older
- Strongly advised to use an accepted and effective method of contraception
- Those with central nervous system (CNS) metastases were eligible if the metastases were treated without advancing symptoms prior to the initiation of chemotherapy
- Those receiving erythropoietin could continue to receive it
EXCLUSION CRITERIA
- Prior radiotherapy for lung cancer; Prior radiotherapy allowed only for central nervous system (CNS) metastases
- Prior chemotherapy for this disease
- Pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT00057837). 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.