Bendamustine With Irinotecan Followed by Etoposide/Carboplatin for Patients With Extensive Stage Small Cell Lung Cancer
Small cell lung cancer, or SCLC, constitutes approximately 15% of the 170,000 new cases of lung cancer diagnosed annually in the United States. Extensive-stage SCLC comprises two thirds of new cases and is generally considered sensitive to chemotherapy, despite a median time to progression of 4 months. SCLC is one of the most aggressive and lethal types of cancer, with a median survival of 9 months (range 7-11 months) in patients diagnosed with extensive disease. Overall, the majority of patients with SCLC die in less than 2 years (2-year survival rates generally less than 10%), and the 5-year survival rate is 2.3% for patients with extensive disease. The regimen of etoposide in combination with a platinum (cisplatin or carboplatin) is generally considered the "standard of care" although a recent Phase III trial suggests improved survival with the combination of cisplatin/irinotecan. Further evaluation of new agents in combination regimens attempting to overcome the intrinsic drug resistance seen in extensive-stage SCLC is warranted attempting to improve survival and achieve palliation of disease-related symptoms.
Checked against the public recordLast updated Jul 17, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- University of Alabama at Birmingham
- Interventions being studied
- Drug: Novel Drug Combination
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Histologic or cytologic diagnosis of extensive stage SCLC. * Measurable or assessable tumor parameters. * 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 * Hemoglobin ≥ 8g/dl * Platelet count ≥ 100,000/µL * SGOT/SGPT ≤ 2 x upper limit of normal or ≤ 5 x upper limit of normal when liver metastases are present. * Total bilirubin value ≤ 2 x upper limit of normal. * Serum creatinine value ≤ 2 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 subjects 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). * Extensive-stage SCLC as defined as disease not confined to one hemithorax, including ipsilateral pleural effusion or pericardial effusion. * No prior chemotherapy. Exclusion Criteria: * 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Alabama at BirminghamBirmingham, Alabama
- Georgia Cancer SpecialistsMarietta, Georgia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 17, 2017. Always confirm current availability with the study team.