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A Phase II, Multi-Center, Open-Label, Trial of PR104 in Treatment Naive and Sensitive-relapse Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Phase II, Multi-Center, Open-Label, Trial of PR104 in Treatment Naive and Sensitive-relapse Small Cell Lung Cancer


OBJECTIVES:

Primary

- Estimate the response rate of PR-104 in patients with treatment-naive or
sensitive-relapse small cell lung cancer.

- Evaluate safety of this drug in these patients. Secondary

- Evaluate survival of these patients.

- Evaluate progression-free survival of these patients.

- Evaluate time to progression in these patients.

- Assess the pharmacokinetics (PK) of PR-104 and its alcohol metabolite.

- Estimate the rate of hypoxia using 18F-fluoromisonidazole (FMISO) positron emission
topography (PET) imaging.

- Collect plasma samples for assessment of potential biomarkers of tumor hypoxia.

OUTLINE: This is a multicenter study. Patients are stratified according to disease type
(treatment-naive vs sensitive-relapse).

Patients receive PR-104 intravenously (IV) over 1 hour on day 1. Treatment repeats every 21
days for up to 4 courses (for treatment-naive patients) or in the absence of disease
progression or unacceptable toxicity (for sensitive-relapse patients).

PK studies are performed during course 1 and after course 3. Blood is collected at baseline,
during course 1, and at study completion for biomarker studies of tumor hypoxia (plasma
proteins). Patients also undergo FMISO PET and fludeoxyglucose F18 (FDG) PET scans at
baseline and after the second course of study therapy.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate (Complete or Partial)

Outcome Time Frame:

From registration until disease progression/recurrence

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

PR104-2001

NCT ID:

NCT00544674

Start Date:

August 2007

Completion Date:

January 2009

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • limited stage small cell lung cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
James Graham Brown Cancer Center at University of LouisvilleLouisville, Kentucky  40202
Front Range Cancer SpecialistsFort Collins, Colorado  80528
University of Florida Health Science Center - JacksonvilleJacksonville, Florida  32209
Stanford Cancer CenterStanford, California  94305-5824
Good Samaritan Hospital Cancer Treatment CenterCincinnati, Ohio  45220
Arizona Clinical Research Center, IncorporatedTucson, Arizona  85715
Tower Cancer Research FoundationBeverly Hills, California  90211
Welborn ClinicEvansville, Indiana  47714
Peninsula Cancer Institute - Newport News OfficeNewport News, Virginia  23601
Kentuckiana Cancer Institute, PLLCLouisville, Kentucky  40202
Gabrail Cancer Center - Canton OfficeCanton, Ohio  44718
California Cancer Care, Incorporated - GreenbraeGreenbrae, California  94904
Pacific Shores Medical Group - Long BeachLong Beach, California  90813
Purchase Cancer Group - PaducahPaducah, Kentucky  42001
Cancer and Blood Specialists of Nevada - HendersonHenderson, Nevada  89074