Interferon Alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: interferon alpha; 13-cis-retinoic acid; paclitaxel
Intervention description: Interferon alpha given subcutaneously, 6 million units per square meter of body surface area on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.; 13-cis-retinoic acid given at 1 mg/kg of body weight by mouth on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.; paclitaxel administered intravenously with premedication at 75 mg/m2 of body surface area on day 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Paclitaxel; Tretinoin; Isotretinoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent small cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop
      tumor cells from dividing so they stop growing or die. Some tumors become resistant to
      chemotherapy drugs. Giving interferon alfa and isotretinoin together with paclitaxel may
      reduce resistance to the drug and allow the tumor cells to be killed.

      PURPOSE: This phase II trial is studying how well giving interferon alfa and isotretinoin
      together with paclitaxel works in treating patients with recurrent small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria

          -  Histologically or cytologically confirmed recurrent small cell lung cancer (SCLC) with
             clinically confirmed measurable disease

          -  Age 18 and over

          -  ECOG Performance status 0-3

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Bilirubin no greater than 1.5 mg/dL

          -  AST no greater than 2 times upper limit of normal (ULN)

          -  Creatinine no greater than 1.5 mg/dL

          -  Triglycerides no greater than 1.5 times ULN

          -  Patients must have had prior chemotherapy treatment for SCLC, and toxicities must have
             resolved to less than or equal to grade 1

          -  Women of childbearing potential and sexually active males are strongly encouraged to
             use an accepted and effective method of contraception.

        Exclusion Criteria

          -  History of another neoplasm other than SCLC except for non-metastatic, non-melanoma
             skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery or small
             field radiotherapy at least 5 years before registration

          -  Pregnant or nursing, with a negative pregnancy test within 2 weeks prior to
             registration

          -  Severe depression requiring medication

          -  Use of the following drugs within 4 weeks prior to registration: carbamazepine,
             ethanol, tetracycline, doxycycline, minocycline, topical acne products containing
             Retin-A, vitamin A, cisplatin, ketoconazole, phenytoin or other antiepileptic drugs

          -  Use of GM-CSF or G-CSF within 4 weeks prior to registration

          -  Prior paclitaxel or interferon therapy

          -  Radiation therapy within 60 days prior to registration

          -  Chemotherapy within 60 days prior to registration