Topotecan Hydrochloride or Cyclodextrin-Based Polymer-Camptothecin CRLX101 in Treating Patients With Recurrent Small Cell Lung Cancer
Condition: Extensive Stage Small Cell Lung Cancer; Recurrent Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma; Recurrence
Intervention: topotecan hydrochloride; cyclodextrin-based polymer-camptothecin CRLX101
Intervention description: Given IV; Given IV
Intervention MeSH terms: Topotecan; Camptothecin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well giving topotecan hydrochloride or
      cyclodextrin-based polymer-camptothecin CRLX101 works in treating patients with recurrent
      small cell lung cancer. Drugs used in chemotherapy, such as topotecan hydrochloride, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Cyclodextrin-based polymer-camptothecin CRLX101 may stop the growth of
      tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know
      whether topotecan hydrochloride is more effective than cyclodextrin-based
      polymer-camptothecin CRLX101 in treating patients with lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed small cell lung cancer

               -  All patients must have extensive stage disease; extensive stage patients are
                  defined as those patients with bilateral or contralateral supraclavicular
                  adenopathy or contralateral hilar adenopathy or malignant pleural effusion or
                  extrathoracic metastatic disease

          -  Patients 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 for
             non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional
             techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic
             resonance imaging (MRI), or calipers by clinical exam

          -  Patients must have been treated with 1 prior platinum-based (cisplatin or carboplatin)
             regimen; prior thoracic radiation for limited stage disease is allowed; patients must
             be at least 4 weeks since prior chemotherapy or radiation

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

          -  Life expectancy of greater than 3 months

          -  Leukocytes >= 3,000/mcL

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Total bilirubin within normal institutional limits

          -  Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 2.5 x institutional upper limit of normal

          -  Creatinine within normal institutional limits OR

          -  Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above
             institutional normal

          -  Baseline imaging studies performed =< 28 days of study registration

          -  The effects of CRLX101 on the developing human fetus are unknown; women of
             child-bearing potential and men must agree to use adequate contraception (hormonal or
             barrier method of birth control; abstinence) prior to study entry and for the duration
             of study participation; should a woman become pregnant or suspect she is pregnant
             while she or her partner is participating in this study, she should inform her
             treating physician immediately; men treated or enrolled on this protocol must also
             agree to use adequate contraception prior to the study, for the duration of study
             participation, and 4 months after completion of CRLX101 administration

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 2 weeks to entering the
             study or those who have not recovered from adverse events due to agents administered
             more than 4 weeks earlier

          -  Patients who have previously been treated with irinotecan or topotecan

          -  Patients who are receiving any other investigational agents

          -  Patients with uncontrolled brain metastases; patients with treated brain metastases
             must have stable neurologic status off of steroids and anticonvulsants for at least 2
             weeks and must be without neurologic dysfunction that would confound the evaluation of
             neurologic and other adverse events

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to CRLX101 or topotecan

          -  Patients with uncontrolled intercurrent illness including, but not limited to ongoing
             or active infection, symptomatic congestive heart failure, unstable angina pectoris,
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements

          -  Previous or concurrent malignancy; exceptions: treated basal cell or squamous cell
             skin cancer, in situ cervical cancer, or lobular carcinoma in situ in one breast; or
             other cancer which the patient has been disease-free >= 5 years

          -  Pregnant women and women who are capable of reproduction but who will not agree to use
             adequate contraception prior to study entry and for the duration of study
             participation; because there is an unknown but potential risk for adverse events in
             nursing infants secondary to treatment of the mother with CRLX101 or topotecan,
             breastfeeding should be discontinued if the mother is treated with either agent

          -  Human immunodeficiency virus (HIV)-positive patients

          -  Patients with history of inflammatory bowel disease requiring therapy or patients with
             chronic diarrhea syndromes or paralytic ileus