Clinical Trial: Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Trial of Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Brief Summary: This proposed phase II trial will investigate the combination of topotecan/carboplatin in the first-line treatment of patients with extensive-stage SCLC. Topotecan/platinum regimens are emerging as common treatments for patients with extensive-stage disease. This trial will be one of the first clinical trials to evaluate a combination of weekly topotecan and carboplatin in the first-line treatment of extensive-stage SCLC.

Detailed Summary:

Eligible patients will receive treatment with carboplatin and topotecan.

Topotecan 4mg/m2 IV on days 1, 8.

Carboplatin AUC=5 IV day 1 only .

- Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)


Sponsor: SCRI Development Innovations, LLC

Current Primary Outcome: Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 months ]

Overall response rate is the percent of patients experiencing a complete or partial response by RECIST v. 1 Criteria. Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.

The final response category assigned represented the best response obtained during treatment.



Original Primary Outcome: Overall response rate

Current Secondary Outcome:

  • Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease [ Time Frame: 18 months ]
    Time to progression is defined as the interval between the start date of treatment and the date of occurrence of progressive disease.
  • Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death [ Time Frame: 18 months ]
    Overall survival was measured from the date of study entry until the date of death.


Original Secondary Outcome:

  • Overall toxicity
  • Time to progression
  • Duration of response
  • Overall survival


Information By: SCRI Development Innovations, LLC

Dates:
Date Received: March 20, 2006
Date Started: March 2006
Date Completion:
Last Updated: January 24, 2013
Last Verified: January 2013