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Sponsors and Collaborators: |
University of Alabama at Birmingham Sanofi-Synthelabo Amgen |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00240097 |
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.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: Irinotecan; Oxaliplatin; Etoposide; Carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment |
Official Title: | 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 |
Estimated Enrollment: | 33 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Untreated patients
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Drug: Irinotecan; Oxaliplatin; Etoposide; Carboplatin
Intervention description:In Part I of the Study(Untreated patients):Patients will be treated with alternating regimens(A and B)--Regimen A:Oxaliplatin-85mg/m2(IV) on day 1 of the cycle plus Irinotecan-150mg/m2(IV) on day 1 of the cycle plus Neulasta 6mg(subc)on day 2 of the cycle,follow by Regimen B: Carboplatin-AUC of 6(IV) on day 15 of the cycle plus Etoposide-100mg/m2(IV) on days 15,16,and 17 of the cycle plus Neulasta-6mg(subc) on day 18 of the cycle.The 2nd cycle will be repeated with Regimen A 3 weeks after the initiation of Regimen B of Cycle 1.A total of 5 cycles will be administered to these patients.In Part II(Relapsed patients):These patients will be treated with Regimen A every 3 weeks for a total of 6-8 cycles of treatment.
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2: Experimental
2nd-line therapy in relapsed patients
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Drug: Irinotecan; Oxaliplatin; Etoposide; Carboplatin
Intervention description:In Part I of the Study(Untreated patients):Patients will be treated with alternating regimens(A and B)--Regimen A:Oxaliplatin-85mg/m2(IV) on day 1 of the cycle plus Irinotecan-150mg/m2(IV) on day 1 of the cycle plus Neulasta 6mg(subc)on day 2 of the cycle,follow by Regimen B: Carboplatin-AUC of 6(IV) on day 15 of the cycle plus Etoposide-100mg/m2(IV) on days 15,16,and 17 of the cycle plus Neulasta-6mg(subc) on day 18 of the cycle.The 2nd cycle will be repeated with Regimen A 3 weeks after the initiation of Regimen B of Cycle 1.A total of 5 cycles will be administered to these patients.In Part II(Relapsed patients):These patients will be treated with Regimen A every 3 weeks for a total of 6-8 cycles of treatment.
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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
Ages Eligible for Study: | 19 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow, liver and renal function, defined as:
Must provide written informed consent and authorization to use and disclose health information (HIPAA).
For Part I
No prior chemotherapy.
For Part II
Exclusion Criteria:
Contact: Francisco Robert, MD | 205-934-5077 |
United States, Alabama | |
University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Francisco Robert, MD 205-934-5077 | |
Sub-Investigator: Robert Diasio, MD |
Principal Investigator: | Francisco Robert, MD | University of Alabama at Birmingham |
Responsible Party: | University of Alabama at Birmingham ( Francisco Robert, M.D. ) |
Study ID Numbers: | F041222002, UAB 0421 |
Study First Received: | October 13, 2005 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00240097 |
Health Authority: | United States: Institutional Review Board |
Thoracic Neoplasms Non-small cell lung cancer Irinotecan Carboplatin Etoposide phosphate Carcinoma Carcinoma, Small Cell |
Oxaliplatin Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Etoposide Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |