Study of Sequential Topoisomerase, Irinotecan/Oxaliplatin - Etoposide /Carboplatin in Extensive Small Cell Lung Cancer (SCLC)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Intervention A: Irinotecan; Oxaliplatin; Neulasta; Intervention B: Etoposide; Carboplatin; Neulasta
Intervention description: 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)
Intervention MeSH terms: Carboplatin; Oxaliplatin; Irinotecan; Etoposide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 19 Years
Maximum age: 80 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologic or cytologic diagnosis of SCLC.

          2. Measurable or assessable tumor parameters.

          3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.

          4. Age between 18 and 79 years (in the State of Alabama > 18).

          5. 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.

          6. Fully recovered from any previous surgery (at least 4 weeks since major surgery)

          7. Must have recovered from prior radiation therapy (at least 3 weeks)

          8. 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.

          9. Must provide written informed consent and authorization to use and disclose health
             information (HIPAA).

             For Part I

         10. Extensive-stage SCLC as defined as disease not confined to one hemithorax, including
             ipsilateral pleural effusion or pericardial effusion.

         11. No prior chemotherapy.

             For Part II

         12. Patients with either refractory disease, or who have relapsed 1st line therapy. No
             prior chemotherapy with Oxaliplatin or irinotecan.

         13. Demonstrated tumor progression at the time of study entry.

        Exclusion Criteria:

          1. Concurrent cancer chemotherapy, biologic therapy or radiotherapy.

          2. Administration of any investigational drug within 28 days prior to administration of
             the current therapy.

          3. Symptomatic brain metastases; those patients should be treated first with either whole
             brain radiation therapy or radiosurgery.

          4. Concurrent serious infection.

          5. 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.

          6. 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.

          7. Neuropathy at baseline ≥ Grade 2.

          8. Any evidence or history of hypersensitivity or other contraindications for the drugs
             used in this trial.

          9. History of chronic diarrhea; or diarrhea (excess of 2-3 stools/day above normal
             frequency) in the past 2 weeks.

         10. History of a positive serology for human immunodeficiency virus (HIV).

         11. Psychiatric disorder that prevents patients from providing informed consent or
             following protocol instructions.

         12. Pregnant or lactating women.