Phase II Study of Abraxane and Gemicitabine in Patients With Advanced Adenocarcinoma Non-Small Cell Lung Cancer Progressing After First-Line Platinum-Based Chemotherapy
Condition: Patients With Stage IV or Recurrent Adenocarcinoma of the Lung
MeSH terms: Adenocarcinoma; Adenocarcinoma of Lung
Intervention: Abraxane; Gemcitabine
Intervention MeSH terms: Gemcitabine; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: a prospective, single-arm, non-randomized, phase II trial designed to evaluate the efficacy of combination gemcitabine and albumin-bound paclitaxel for advanced adenocarcinoma non-small cell lung cancer progressing after first-line platinum-based chemotherapy.
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to see how well the combination of Abraxane and gemcitabine
      works in people with advanced adenocarcinoma NSCLC who have already had treatment for their
      disease. Gemcitabine and Abraxane are FDA approved chemotherapies; however, the FDA has not
      approved this combination in the treatment of this specific type of cancer. Patients may
      continue to receive the study drugs until their disease gets worse or they have unacceptable
      side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic diagnosis of adenocarcinoma non-small cell lung cancer

          -  Stage IV non-small cell lung cancer or recurrent disease which cannot be approached
             with curative intent.

          -  First-line treatment with a standard platinum doublet chemotherapy regimen
             (carboplatin or cisplatin at standard dosing plus one of the following drugs at
             standard dosing: paclitaxel, docetaxel, vinblastine, vinorelbine, pemetrexed, or
             etoposide). Patients who received platinum-based chemotherapy for localized lung
             cancer (either adjuvant chemotherapy following surgery or chemotherapy given in
             conjunction with definitive radiation) are eligible if their cancer has recurred
             within 6 months of platinum-based chemotherapy.

          -  Must have recovered from toxic effects of prior chemotherapy

          -  ECOG performance status of 0-1

          -  Life expectancy of at least 12 weeks

          -  Age 18 or greater

          -  Must have measurable disease defined as at least one lesion that can be accurately
             measured in at least one dimension (longest diameter to be recorded as > 20 mm with
             conventional techniques or > 10 mm with spiral CT scanning).

          -  Patients with prior malignancies are allowed, provided they have been treated with
             curative intent and have no evidence of active disease.

          -  Patients must be capable of giving informed consent and be willing and able to comply
             with scheduled visits, treatment plan and laboratory testing.

          -  Bilirubin < 1.5 mg/dL

          -  Patients must have adequate liver function: AST and ALT < 2.5 X upper limit of normal,
             alkaline phosphatase < 2.5 X upper limit of normal, unless bone metastasis is present
             in the absence of liver metastasis

          -  Patients must have adequate bone marrow function: Platelets >100,000 cells/mm3,
             Hemoglobin > 9.0g/dL and ANC > 1,500 cells/mm3

          -  Patients must have adequate renal function: creatinine <1.5 mg/dL

          -  Women of childbearing potential and sexually active males must use an effective
             contraception method during treatment and for three months after completing treatment

          -  Negative serum β-hCG pregnancy test at screening for patients of childbearing
             potential.

          -  Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE)

        Exclusion Criteria:

          -  Patients with EGFR or EML4-ALK mutations

          -  ECOG performance status >1

          -  Patients previously treated with gemcitabine or Abraxane

          -  Uncontrolled intercurrent illness including, but not limited to: uncontrolled ongoing
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Known HIV or Hepatitis C

          -  Untreated central nervous system metastases. Patients are eligible if they are
             clinically stable, off all steroids after cranial irradiation (whole brain radiation
             therapy, focal radiation therapy, stereotactic radio surgery) ending at least 2 weeks
             prior to enrollment, or after surgical resection performed at least 2 weeks prior to
             enrollment.

          -  Concurrent treatment with other anticancer therapy, including other chemotherapy,
             immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy,
             or an investigational agent

          -  Pregnant or breast-feeding patients, as chemotherapy is thought to present substantial
             risk to the fetus/infant. Men and women of reproductive potential may not participate
             in this study unless they have agreed to use an effective contraceptive method while
             in this study. (Postmenopausal woman must have been amenorrheic for at least 12 months
             to be considered of non-childbearing potential). Patients must agree to continue
             contraception for 3 months from the date of the last study drug administration