Chemotherapy and Radiotherapy to Treat Patients With Limited Stage of Small Cell Lung Cancer (SCLC)
- Conditions
- Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00494026
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This is a multicenter, phase II, open-label trial to evaluate the efficacy of pemetrexed + carboplatin combined with thoracic radiotherapy in patients with Limited Stage of small cell lung cancer
- Detailed Description
Two 21-day cycles of pemetrexed (500 milligrams per square meter \[mg/m2\] intravenous \[IV\] infusion) and carboplatin (target area under the curve \[AUC\] 5 IV infusion) followed by two 21-day cycles of pemetrexed (500 mg/m2 IV infusion) and carboplatin (target AUC 5 IV infusion) with concurrent radiotherapy (2 Gray \[Gy\] per fraction, 5 fractions per week, up to a dose of 50 Gy is administered).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
- Histologic and/or cytologic diagnosis of Limited Stage of small cell lung cancer
- Measurable disease
- Good performance status
- Adequate bone marrow reserve, hepatic, pulmonary and renal functions
- Serious concomitant systemic disorder
- Prior chemotherapy for this cancer and/or prior thoracic radiotherapy
- Pregnancy/breast-feeding
- Significant weight loss over the previous 6 weeks before study entry
- Inability or unwillingness to take vitamin supplementation and corticosteroids
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pemetrexed + Carboplatin pemetrexed - Pemetrexed + Carboplatin carboplatin - Pemetrexed + Carboplatin radiotherapy -
- Primary Outcome Measures
Name Time Method Proportion of Patients With a Complete or Partial Response (Overall Response Rate [ORR]) baseline to measured response after chemotherapy and radiation Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.
- Secondary Outcome Measures
Name Time Method Progression-free Survival baseline to measured progressive disease Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.
Overall Survival baseline to date of death from any cause, 1 year Overall survival is the duration from enrollment to death (includes 1 year follow-up). For patients who are alive, overall survival is censored at the last contact.
Duration of Response time of response to progressive disease The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Pharmacology Toxicity every 21-day cycle for 4 cycles Radiation Therapy Oncology Group (RTOG) criteria were used for assessing toxicity. Toxicity grade reflected the most severe degree occurring during the evaluated period, not an average. When two criteria were available for similar toxicities, the one resulting in the more severe grade was used. Toxiccity grades range from 0 to 5. Toxicity grade = 5 if that toxicity caused the death of the patient.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇬🇧Wolverhampton, West Midlands, United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.🇬🇧Wolverhampton, West Midlands, United Kingdom