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

• Status: Terminated
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Proacta, Incorporated

Criteria

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