Bendamustine With Irinotecan Followed by Etoposide/Carboplatin for Patients With Extensive Stage Small Cell Lung Cancer

Completed · Phase 1/Phase 2

Conditions studied: Small Cell Lung Cancer, Extensive Stage Lung Cancer, Chemonaive

In brief

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.

Key facts

Study ID

NCT00856830

Run by

University of Alabama at Birmingham

People needed

30

Starts

2009-04-01

Expected to finish

2016-05-01

Last updated by the study team

2017-07-17

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Georgia Cancer Specialists — Marietta, Georgia, United States

Full record on ClinicalTrials.gov

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