Nab-Paclitaxel With Gemcitabine for Relapsed Small Cell Cancer
Condition: Small Cell Lung Cancer (SCLC)
MeSH terms: Small Cell Lung Carcinoma; Carcinoma, Small Cell
Intervention: Nab-paclitaxel; Gemcitabine
Intervention description: Nab-paclitaxel 100 mg/m2, day 1 and day 8 of a 21-day cycle; Gemcitabine 1000 mg/m2, day 1 and day 8 of a 21-day cycle
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Abraxane; Albumin-bound Paclitaxel; SCLC; Gemzar

Summary:

      The purpose of this research study is to see if Abraxane and Gemcitabine given together will
      be effective in treating small cell cancer that has progressed after one line of treatment.
    

Eligibility criteria:

        Inclusion criteria

          1. Age ≥18 years old, both male and female

          2. Histologically or cytologically confirmed SCLC SCLC or small cell cancer from other
             organs or poorly differentiated neuroendocrine tumors that are treated like small cell
             cancer. This study is for patients with metastatic or recurrent disease.

          3. ECOG performance status 0-2

          4. Patients must have at least one measurable lesion as defined per RECIST 1.1

          5. Progression during or after prior first line chemotherapy. Prior maintenance therapy,
             targeted therapy and immunotherapy are allowed. Prior use of Rovalpituzumab or other
             ADC agent is allowed. Immunotherapy or targeted therapy if used as 2nd line therapy
             will not be considered as second line therapy as these are not true chemotherapeutic
             agents. Patients treated with definitive chemo-radiation will be eligible if they
             progressed within a year of definitive therapy (as definitive therapy will be
             considered 1st line therapy for these patients).

          6. Before study therapy, a minimum of 21 days must have elapsed since any prior
             chemotherapy and 2 weeks from the last dose of prior targeted or immunotherapy.

          7. Prior definitive XRT is allowed if it has been 2 weeks since the end of definitive
             XRT. For palliative XRT, protocol-specified treatment can begin at minimum 48 hours
             after completion of radiation. Lesions within the XRT field can only be used as target
             lesions if definite progression has been demonstrated since the completion of
             radiation.

          8. Adequate major organ function including the following:

               -  Hematologic function: Absolute neutrophil count (ANC) ≥ 1800 /mm3, platelet count
                  ≥ 100,000/mm3, and Hgb ≥ 9.0 gm/dl.

               -  Hepatic function: bilirubin ≤ 1.5 x ULN, AST and ALT levels ≤ 2.5 x ULN. If liver
                  metastases are present, then AST and ALT ≤ 5 x ULN.

               -  Renal function: serum creatinine ≤ 1.5 x ULN.

          9. Patients must be willing and able to sign informed consent for themselves

         10. If female: childbearing potential either terminated by surgery, radiation, or
             menopause, or attenuated by use of an approved contraceptive method (intrauterine
             device [IUD], birth control pills, or barrier device) during and for 6 months after
             trial. If male, use of an approved contraceptive method during the study and 6 months
             afterwards. Females with childbearing potential must have a urine negative hCG test
             within 7 days prior to the study therapy.

             Females of child-bearing potential (defined as a sexually mature woman who (1) has not
             undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy
             [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal
             for at least 24 consecutive months [i.e., has had menses at any time during the
             preceding 24 consecutive months]) must:

             Either commit to true abstinence* from heterosexual contact (which must be reviewed on
             a monthly basis), or agree to use, and be able to comply with, effective contraception
             without interruption, 28 days prior to starting IP therapy (including dose
             interruptions), and while on study medication or for a longer period if required by
             local regulations following the last dose of IP; and

             Have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing
             pregnancy testing during the course of the study, as per clinical judgement of the
             investigator, and after the end of study therapy. This applies even if the subject
             practices true abstinence* from heterosexual contact.

         11. Male subjects must practice true abstinence* or agree to use a condom during sexual
             contact with a pregnant female or a female of childbearing potential while
             participating in the study, during dose interruptions and for 6 months following IP
             discontinuation, even if he has undergone a successful vasectomy.

               -  True abstinence is acceptable when this is in line with the preferred and usual
                  lifestyle of the subject. [Periodic abstinence (eg, calendar, ovulation,
                  symptothermal, post-ovulation methods) and withdrawal are not acceptable methods
                  of contraception].

        Exclusion criteria

          1. Any of the following because this study involves an agent that has known genotoxic,
             mutagenic, and teratogenic effects:

               -  Pregnant women

               -  Nursing women

               -  Men or women of childbearing potential, who are unwilling to employ adequate
                  contraception as determined by treating physician, while on this study and for 6
                  months after the end of treatment with the study drugs.

          2. History of the following within the prior 6 months: a myocardial infarction,
             severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York
             Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension,
             clinically significant cardiac dysrhythmia or clinically significant ECG abnormality,
             cerebrovascular accident, transient ischemic attack, or seizure disorder

          3. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose
             control may be jeopardized by complication of study therapy

          4. History of other invasive malignancy that is currently active and/or has been treated
             within 12 months prior to enrollment (notable exceptions include: basal cell
             carcinoma, squamous cell carcinoma of the skin, localized prostate cancer, in situe
             carcinomas of the cervix and breast, and superficial bladder cancers [non-muscle
             invasive]).

          5. Psychiatric disorder which, per treating physician discretion, may preclude compliance

          6. Major surgery in the last two weeks of starting study therapy. This does not include
             procedures like biopsy (needle or excisional) or port placement as these are not
             considered as major surgery.

          7. Individuals with the presence of symptomatic CNS metastasis requiring radiation,
             surgery, or ongoing use of corticosteroids. Untreated or brain metastasis causing any
             symptoms. Treated brain metastasis must be stable for 4 weeks prior to first dose of
             study drug and not require steroids for at least 7 days prior to study treatment.

          8. Pre-existing peripheral neuropathy > Grade 1 (using CTCAE v 4.3 criteria)

          9. Received any prior treatment with any taxane (docetaxel or paclitaxel) for small cell
             lung cancer.

         10. History of allergy or hypersensitivity to albumin-bound paclitaxel, or gemcitabine.