Extensive Stage Small Cell Lung Cancer Clinical Trial
Official title:
A Phase II Study of AT-101 in Recurrent Extensive Stage Small Cell Lung Cancer
This phase II trial is studying how well R-(-)-gossypol acetic acid works in treating patients with recurrent extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as R-(-)-gossypol acetic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Status | Completed |
Enrollment | 15 |
Est. completion date | August 2010 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically or cytologically confirmed small cell lung cancer - Extensive stage disease - Recurrent disease - Measurable disease - Chemotherapy-sensitive disease, defined as: - No progression during first-line chemotherapy - No disease recurrence < 2 months after completion of first-line chemotherapy - Must have received prior platinum-based chemotherapy - No symptomatic or progressive brain metastases - Patients with previously treated brain metastases who are clinically and radiographically stable or improved and have been off steroids = 14 days are eligible - ECOG performance status 0-2 - Life expectancy > 12 weeks - Leukocytes = 3,000/µL - ANC = 1,500/µL - Platelet count = 100,000/µL - Total bilirubin < 1.5 mg/dL - AST and ALT = 2.5 times upper limit of normal - Serum creatinine = 1.5 mg/dL OR creatinine clearance = 60 mL/min - Hemoglobin > 8 g/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception before, during, and for 30 days after completion of study therapy - Able to take oral medications on a regular basis - Willing to provide blood samples for mandatory correlative studies - No condition that impairs the ability to swallow and retain R-(-)-gossypol tablets, including the following: - Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation - Active peptic ulcer disease - No malabsorption syndrome or disease significantly affecting gastrointestinal function - No ulcerative colitis, inflammatory bowel disease, or a partial or complete small bowel obstruction - No uncontrolled concurrent illness including, but not limited to, any of the following: - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Psychiatric illness or social situations that would limit compliance with study requirements - No symptomatic hypercalcemia > grade 2 - No requirement for routine use of hematopoietic growth factors (including G-CSF, GM-CSF, or IL-11) or platelet transfusions to maintain ANC or platelet counts - No history of allergic reactions attributed to compounds of similar chemical or biologic composition to R-(-)-gossypol - No HIV positivity - Recovered from all prior therapy, including prior surgical procedures - No prior surgical procedures affecting absorption - No prior resection of the stomach or small bowel - No more than one prior chemotherapy regimen - No prior racemic gossypol or R-(-)-gossypol - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) - At least 4 weeks since prior radiotherapy, hormonal agents, or biologic response modifiers - At least 4 weeks since prior and no concurrent investigational agents or devices - No concurrent prophylactic hematopoietic growth factors (including filgrastim [G-CSF], sargramostim [GM-CSF], or interleukin-11 [IL-11]) during course one - No concurrent combination antiretroviral therapy for HIV-positive patients |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR) | The number of successes will be estimated by counting the number of participants with confirmed responses. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: A Complete Response (CR) requires the disappearance of all target lesions A Partial Response (PR) requires a >=30% decrease in the sum of the longest diameter of target lesions from baseline measurements. |
During the first 6 courses of treatment | No |
Secondary | Survival Time | Estimated using the method of Kaplan-Meier. | From registration to death due to any cause, assessed up to 5 years | No |
Secondary | Time to Disease Progression | Time to disease progression is defined as the time from registration to the earliest date documentation of disease progression. Estimated using the method of Kaplan-Meier. Per the RECIST criteria, progression is defined as at least a 20% increase in the sum of Longest Dimension (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
From registration to the earliest date documentation of disease progression, assessed up to 5 years | No |
Secondary | Duration of Response | From the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented, assessed up to 5 years | No |
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