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

Stopped early · Phase 2

Conditions studied: Lung Cancer

In brief

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).

Key facts

Study ID

NCT00544674

Run by

Proacta, Incorporated

People needed

5

Starts

2007-08-01

Expected to finish

2009-01-01

Last updated by the study team

2012-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Clinical Research Center, Incorporated — Tucson, Arizona, United States
• Tower Cancer Research Foundation — Beverly Hills, California, United States
• California Cancer Care, Incorporated - Greenbrae — Greenbrae, California, United States
• Pacific Shores Medical Group - Long Beach — Long Beach, California, United States
• Stanford Cancer Center — Stanford, California, United States
• Front Range Cancer Specialists — Fort Collins, Colorado, United States
• University of Florida Health Science Center - Jacksonville — Jacksonville, Florida, United States
• Joliet Oncology-Hematology Associates, Limited - West — Joliet, Illinois, United States
• Welborn Clinic — Evansville, Indiana, United States
• James Graham Brown Cancer Center at University of Louisville — Louisville, Kentucky, United States
• Kentuckiana Cancer Institute, PLLC — Louisville, Kentucky, United States
• Purchase Cancer Group - Paducah — Paducah, Kentucky, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Cancer and Blood Specialists of Nevada - Henderson — Henderson, Nevada, United States
• Gabrail Cancer Center - Canton Office — Canton, Ohio, United States
• Charles M. Barrett Cancer Center at University Hospital — Cincinnati, Ohio, United States
• Good Samaritan Hospital Cancer Treatment Center — Cincinnati, Ohio, United States
• Peninsula Cancer Institute - Newport News Office — Newport News, Virginia, United States

Full record on ClinicalTrials.gov

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