Phase II Study of Dose-Intense Chemotherapy With Sequential Topoisomerase Targeting With Irinotecan/Oxaliplatin Followed by Etoposide/Carboplatin in Patients With Extensive Small Cell Lung Cancer or Stage IIIb - IV Large Cell Carcinoma of the Lung
This is a Phase II, open label study for either chemotherapy-naïve patients with extensive
SCLC or patients who are refractory or have relapsed to 1st line therapy for SCLC. The
primary objective is to determine the objective response rate.
This study consists of 2 parts:
Part I - Chemotherapy-naïve patients with extensive SCLC
• These patients will be treated with sequential topoisomerase targeting regimens (Regimen A
and B). Regimen A consists of irinotecan and oxaliplatin (IROX), given on Day 1, and
Neulasta administered on Day 2. Regimen B consists of etoposide and carboplatin, given on
Day 15(etoposide will be given daily x 3)and Neulasta on Day 18. Then, Regimen A will be
given again 3 weeks later. The first re-evaluation for response will be performed 3 weeks
after the second round of the sequential regimens.
Schema of Part I:
Regimen A (→ 2 weeks) Regimen B (→ 3 weeks) Regimen A (→ 2 weeks) Regimen B → (3 weeks) →
Re-Stage
- The second re-evaluation for response will be performed 3 weeks after the fourth round
of the sequential regimen. At this point patients with stable disease will be
observed; those with either a partial or complete response will be treated with another
round of sequential therapy (Regimen A → Regimen B) if there is no evidence of
unacceptable toxicity. At the end (3 weeks after) of the fifth round of chemotherapy,
patients will be re-evaluated for response, and will be followed-up for recurrent
disease every 8 weeks.
- Analysis of Top I and Top II levels in peripheral blood mononuclear cells will be
performed in 10 patients of Part I.
- Evaluation of the expression of the ERCC genes (ERCC1, ERCC2, and XPF) will be
performed in those patients in Part I with an adequate tumor specimen.
Part II - Patients who have either refractory disease or have relapsed from 1st line therapy
• These patients will be treated with Regimen A1 (IROX) at 3-week intervals. Neulasta will
be administered on Day 2 of each cycle. The first re-evaluation for response will be
performed 3 weeks after the 3rd cycle of Regimen A1. The second re-evaluation for response
will be performed 3 weeks after the 6th cycle of Regimen A1. At this point, patients with
stable disease will be observed; those with either a partial or complete response will be
treated with two additional cycles of Regimen A1 if there is no evidence of unacceptable
toxicity. At the end (3 weeks after) of the 8th cycle of Regimen A1, patients will be
re-evaluated for response, and will be followed-up for recurrent disease every 8 weeks.
Schema of Part II:
Regimen A1 (→ 3 weeks) Regimen A1 (→ 3 weeks) Regimen A1 (→ 3 weeks) Re-Stage
Interventional
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the objective tumor response rates
6 months
No
Francisco Robert, MD
Principal Investigator
University of Alabama at Birmingham
United States: Institutional Review Board
F041222002
NCT00240097
June 2005
June 2010
Name | Location |
---|---|
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |