Status:
COMPLETED
Study of Sequential Topoisomerase, Irinotecan/Oxaliplatin - Etoposide /Carboplatin in Extensive Small Cell Lung Cancer (SCLC)
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Sanofi-Synthelabo
Amgen
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
19-80 years
Phase:
PHASE2
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-na...
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00240097
Start Date
June 1 2005
End Date
June 1 2010
Last Update
November 27 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294