Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: Paclitaxel in Treating Patients With Lung Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have unresectable stage IIIB, stage IV or recurrent lung cancer.

Detailed description: OBJECTIVES:
  -  Assess the therapeutic activity of paclitaxel in patients with bronchoalveolar carcinoma (BAC).
  -  Assess the duration of response in patients presenting with an objective response.
  -  Characterize the acute side effects of paclitaxel in patients with BAC.
  -  Assess the role of some biological parameters in the natural history and the response to therapy of BAC; evaluate the expression of Ki67, p53, and K-ras mutation.
  OUTLINE: This is an open label, nonrandomized, multicenter study.
  Paclitaxel is administered every 3 weeks as a 3 hour continuous infusion in dextrose or normal saline. Patients are treated for a minimum of 2 cycles unless serious toxicity or complication occur.
  Disease is assessed every 6 weeks until documented progression; treatment side effects are assessed separately for each cycle of therapy. Treatment is given up to a maximum of 6 cycles of therapy or until disease progression, unacceptable toxicity, or patient refusal occurs.
  PROJECTED ACCRUAL: 16 or 25 patients will be accrued.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven bronchoalveolar carcinoma (BAC) based on these criteria:
  -  Absence of primary adenocarcinoma elsewhere
  -  Absence of a demonstrable central bronchogenic origin
  -  A peripheral location in the lung parenchyma
  -  Intact interstitial framework of the lung
  -  A histological appearance setting it apart from other tumors, with a characteristic pattern of growth: cuboidal or cylindrical cells lining up the alveolar septa with preservation of basic pulmonary architecture
  -  Must be unresectable Stage IIIB, IV, or recurrent BAC
  -  Evidence of multinodular lesions involving the lungs bilaterally or unilaterally (in the latter the lesions must involve more than one lobe)
  -  At least one target lesion bidimensionally measurable that has not undergone prior irradiation
  -  No CNS disease
  PATIENT CHARACTERISTICS:
  Age:
  -  18 to 75 (inclusive)
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  Greater than 3 months
  Hematopoietic:
  -  ANC at least 1,500/mm^3
  Hepatic:
  -  Bilirubin less than 2 times upper limit of normal
  -  SGOT, SGPT, and alkaline phosphatase less than 2 times upper limit of normal
  Renal:
  -  Creatinine less than 1.5 times upper limit of normal
  Cardiovascular:
  -  No history of ischemic or congestive heart disease
  -  No arrhythmia requiring chronic cardiopulmonary medications
  -  No history of clinically or electrographically documented myocardial infarction
  Other:
  -  No preexisting motor or other serious sensory neurotoxicity
  -  No active or prior second primary cancer except basal cell carcinoma of the skin or carcinoma in situ of the cervix
  -  No clinical evidence of uncontrolled infection
  -  Not pregnant or nursing
  -  Negative pregnancy test 72 hours prior to start of study medication
  -  Adequate contraception required of all fertile patients
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  No prior chemotherapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  At least 4 weeks since radiotherapy
  -  Must have at least one bidimensional lesion outside the irradiated fields
  Surgery:
  -  Fully recovered from any prior major surgery

Relevance to patient case: not relevant