NCT00061854CompletedPhase 2
A Phase II Study Of Intravenous TZT-1027, Administered Weekly Times Two, Every Three Weeks, To Patients With Progressive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC) Following Treatment With Platinum-Based Chemotherapy
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Daiichi Sankyo
- Locations
- 5
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •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)
- •Creatinine no greater than 1.5 times ULN
- •Ejection fraction at least 40% by MUGA
- •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
- •At least 4 weeks since prior major surgery and recovered
- •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
Exclusion Criteria
- Not provided
Investigators
Study Sites (5)
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