Trial Search Results

PR104 in Treating Patients With Previously Untreated or Relapsed Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well PR-104 works in treating patients with previously untreated or relapsed small cell lung cancer (SCLC).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Proacta, Incorporated

Stanford Investigator(s):

Intervention(s):

  • Drug: PR104
  • Other: F-18-fluoromisonidazole

Phase:

Phase 2

Eligibility


DISEASE CHARACTERISTICS:

Inclusion criteria:

   - Histologically or cytologically confirmed small cell lung cancer (SCLC)

   - If patient is treatment-naive, then they must have extensive disease

   - If patients are not treatment-naive, then they must be classified as sensitive-relapse
   with either extensive disease or limited disease

      - Sensitive-relapse defined as disease that responded to first-line chemotherapy
      and relapsed more than 90 days following the last dose of first-line chemotherapy

      - Limited disease SCLC defined as disease confined to the hemithorax of origin,
      mediastinum, and/or ipsilateral supraclavicular lymph nodes, which could be
      encompassed within a tolerable radiotherapy port

      - Extensive disease defined as disease that does not fit the definition of limited
      disease as defined above

   - Measurable or evaluable disease

Exclusion criteria:

   - Active central nervous system (CNS) metastases, defined as metastases to the CNS
   (symptomatic or non-symptomatic) that requires immediate treatment or that are likely
   to require treatment in the following 6 weeks

   - Medical conditions requiring urgent intervention, including any of the following:

      - Superior vena cava syndrome

      - Lobar obstruction

      - Spinal cord compression

      - Liver metastases involving greater than one-third of the liver

PATIENT CHARACTERISTICS:

Inclusion criteria:

   - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

   - Absolute neutrophil count ≥ 1,500/mm^3

   - Platelet count ≥ 100,000/mm^3

   - Hemoglobin ≥ 9 g/dL (no red blood cell transfusions allowed)

   - Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)

   - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN (if
   liver metastases are present) or ≤ 2 x ULN (if liver metastases are absent)

   - Serum creatinine ≤ 1.5 x ULN

   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must use effective contraception during and for at least 30 days
   after completion of study treatment

Exclusion criteria:

   - Prior or concurrent malignancies, except for adequately treated basal cell or squamous
   cell carcinoma of the skin, carcinoma in situ of the cervix, or localized low-grade
   prostate cancer

   - Hyponatremia (< 130 mmol/L)

   - Evidence of a significant medical disorder or laboratory finding that, in the opinion
   of the investigator, compromises the patient's safety during study participation,
   including any of the following:

      - Uncontrolled infection or infection requiring a concurrent parenteral antibiotic

      - Uncontrolled diabetes

      - Congestive heart failure

      - Myocardial infarction within the past 6 months

      - Chronic renal disease

      - Coagulopathy (excluding prophylactic anticoagulation)

   - Known human immunodeficiency virus (HIV) positivity, hepatitis B surface
   antigen-positivity, or hepatitis C positivity with abnormal liver function tests

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

   - See Disease Characteristics

   - No concurrent prophylactic growth factors (filgrastim [G-CSF] or sargramostim
   [GM-CSF]) during course 1 of study treatment

Exclusion criteria:

   - More than one prior chemotherapy regimen for SCLC

   - Less than 24 hours from any prior radiotherapy or the likelihood of toxicity from
   prior radiotherapy

   - Radiotherapy to > 25% of the bone marrow within the past 4 weeks

   - Less than four weeks since major surgery

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ruth Lira
6507231367
Not Recruiting