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About
The primary objective of Part I of the study is to determine tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide /carboplatin in chemotherapy-naïve patients with extensive small cell lung cancer. The primary objective of Part II of the study is to determine the objective tumor response rate of irinotecan/oxaliplatin in patients with either refractory disease or who have relapsed to first line chemotherapy or chemoradiotherapy.
Full description
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
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
Enrollment
Sex
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Volunteers
Inclusion criteria
Histologic or cytologic diagnosis of SCLC.
Measurable or assessable tumor parameters.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
Age between 18 and 79 years (in the State of Alabama > 18).
Adequate bone marrow, liver and renal function, defined as:
Fully recovered from any previous surgery (at least 4 weeks since major surgery)
Must have recovered from prior radiation therapy (at least 3 weeks)
All participants must agree to practice approved methods of birth control (if applicable). A negative pregnancy test must be documented during the screening period for women of childbearing potential.
Must provide written informed consent and authorization to use and disclose health information (HIPAA).
For Part I
Extensive-stage SCLC as defined as disease not confined to one hemithorax, including ipsilateral pleural effusion or pericardial effusion.
No prior chemotherapy.
For Part II
Patients with either refractory disease, or who have relapsed 1st line therapy. No prior chemotherapy with Oxaliplatin or irinotecan.
Demonstrated tumor progression at the time of study entry.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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