Lung Cancer Clinical Trial
Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Summary
RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have progressive locally advanced or metastatic non-small cell lung cancer.
Full Description
OBJECTIVES:
Determine the objective tumor response rate and duration of response in patients with progressive locally advanced or metastatic non-small cell lung cancer treated with soblidotin as second-line therapy after receiving prior platinum-based chemotherapy.
Determine the time to tumor progression in patients treated with this drug.
Determine the median survival time and 12-month survival rate of patients treated with this drug.
Determine the quantitative and qualitative toxic effects of this drug in these patients.
Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive soblidotin IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Plasma sampling for pharmacokinetics is done on day 1 of course 1.
Patients are followed for survival every 3 months after discontinuing study treatment.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 1 year.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
Locally advanced or metastatic disease
Demonstrates tumor progression
Must have received 1 prior chemotherapy regimen
Prior chemotherapy must have included a platinum agent
Measurable disease
At least 1 measurable lesion outside the field of any prior radiotherapy
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
ECOG 0-2
Life expectancy
At least 12 weeks
Hematopoietic
Absolute neutrophil count at least 1,500/mm^3
Platelet count greater than 100,000/mm^3
Hepatic
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases are present)
Renal
Creatinine no greater than 1.5 times ULN
Cardiac
Ejection fraction at least 40% by MUGA
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No psychiatric disorder that would preclude giving informed consent or following study instruction
No grade 2 or greater neurotoxicity
No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless in complete remission and off therapy for that disease for at least 5 years prior to study entry
No other concurrent severe or uncontrolled underlying medical disease that would compromise patient safety and study outcome
No concurrent serious infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
No concurrent anticancer biologic therapy
Chemotherapy
See Disease Characteristics
Recovered from prior chemotherapy
No other concurrent anticancer chemotherapy
Endocrine therapy
Not specified
Radiotherapy
See Disease Characteristics
Recovered from prior radiotherapy
No concurrent anticancer radiotherapy
Concurrent localized radiotherapy to a non-indicator lesion for pain relief is allowed provided other methods of pain control are ineffective
Surgery
At least 4 weeks since prior major surgery and recovered
Other
At least 4 weeks since prior myelosuppressive therapy
More than 28 days since prior investigational drugs
No other concurrent investigational drugs
No other concurrent anticancer cytotoxic therapy
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There are 3 Locations for this study
Waterbury Connecticut, 06708, United States
Detroit Michigan, 48201, United States
New York New York, 10021, United States
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