Study of Sequential Topoisomerase, Irinotecan/Oxaliplatin - Etoposide /Carboplatin in Extensive Small Cell Lung Cancer (SCLC)
2 other identifiers
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 nonsmall-cell-lung-cancer
Started Jun 2005
Typical duration for phase_2 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 13, 2005
CompletedFirst Posted
Study publicly available on registry
October 17, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
November 27, 2014
CompletedNovember 27, 2014
November 1, 2014
5 years
October 13, 2005
June 8, 2012
November 26, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Objective Response Rate (Part I)
The primary objective is to determine the objective tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-naïve patients with extensive SCLC and Stage IIIb (wet) - IV Large Cell Carcinoma of the Lung with neuroendocrine markers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable response means did not meet criteria for progressive or partical response. 20% progressive disease.
baseline to 18 months
Response Rate After Relapse
The objective is to determine the objective tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-naïve patients with extensive SCLC and Stage IIIb (wet) - IV Large Cell Carcinoma of the Lung with neuroendocrine markers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable response means did not meet criteria for progressive or partical response. 20% progressive disease.
3 weeks after 3rd cycle of starting therapy after relapse or refractory disease
Secondary Outcomes (2)
Progression Free Survival (Part I)
baseline to five years
Overall Survival (Part I)
baseline to 2 years
Study Arms (2)
Irinotecan; Oxaliplatin; Neulasta
EXPERIMENTALIrinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)
Etoposide; Carboplatin; Neulasta
EXPERIMENTALEtoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) area under the concentration curve (AUC) 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)
Interventions
Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)
Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)
Eligibility Criteria
You may qualify if:
- 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:
- Absolute neutrophil count (ANC) ≥ 1500/µL
- Platelet count ≥ 100,000/µL
- SGOT/SGPT ≤ 2.5 x upper limit of normal or ≤ 5 x upper limit of normal when liver metastases are present.
- Total bilirubin value ≤ 1.5 x upper limit of normal.
- Serum creatinine value ≤ 1.5 x upper limit of normal.
- 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
- +5 more criteria
You may not qualify if:
- Concurrent cancer chemotherapy, biologic therapy or radiotherapy.
- Administration of any investigational drug within 28 days prior to administration of the current therapy.
- Symptomatic brain metastases; those patients should be treated first with either whole brain radiation therapy or radiosurgery.
- Concurrent serious infection.
- Concomitant severe or uncontrolled underlying medical disease unrelated to the tumor, which is likely to compromise patient safety and affect the outcome of the study.
- History of other malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for a minimum of 2 years.
- Neuropathy at baseline ≥ Grade 2.
- Any evidence or history of hypersensitivity or other contraindications for the drugs used in this trial.
- History of chronic diarrhea; or diarrhea (excess of 2-3 stools/day above normal frequency) in the past 2 weeks.
- History of a positive serology for human immunodeficiency virus (HIV).
- Psychiatric disorder that prevents patients from providing informed consent or following protocol instructions.
- Pregnant or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- Sanofi-Synthelabocollaborator
- Amgencollaborator
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Related Publications (1)
Rossman J, Reddy V, Cantor A, Miley D, Robert F. Phase II study of dose-intense chemotherapy with sequential topoisomerase-targeting regimens with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy naive patients with extensive small cell lung cancer. Lung Cancer. 2011 May;72(2):219-23. doi: 10.1016/j.lungcan.2010.08.023. Epub 2010 Oct 8.
PMID: 20934233DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Francisco Robert
- Organization
- UAB
Study Officials
- PRINCIPAL INVESTIGATOR
Francisco Robert, MD
University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
October 13, 2005
First Posted
October 17, 2005
Study Start
June 1, 2005
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
November 27, 2014
Results First Posted
November 27, 2014
Record last verified: 2014-11