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

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: National Comprehensive Cancer Network
• Treatments: Bendamustine Hydrochloride; Camptothecin; Carboplatin; Etoposide; Etoposide phosphate; Irinotecan

Criteria

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.