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
18 Years
N/A
Both
Lung Cancer
Trial Information
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
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.
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:
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Peter Cheverton, MD, ChB, MMED, RadT
Investigator Role:
Study Chair
Investigator Affiliation:
Daiichi Pharmaceuticals
Authority:
United States: Federal Government
Study ID:
CDR0000301749
NCT ID:
NCT00061854
Start Date:
April 2003
Completion Date:
May 2005
Related Keywords:
- Lung Cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- recurrent non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Medical Oncology and Hematology, P.C. | Hamden, Connecticut 06518 |
