A Phase I Study of NX211 Given as an IV Infusion Days 1, 2 and 3 Every 3 Weeks in Patients With Solid Tumors
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Study of NX211 Given as an IV Infusion Days 1, 2 and 3 Every 3 Weeks in Patients With Solid Tumors
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and the future dose of lurtotecan
liposome in patients with advanced solid tumors. II. Assess the toxicity and
pharmacokinetics of this treatment regimen in this patient population. III. Assess the
response to this regimen by patients with measurable disease.
OUTLINE: This is a dose escalation, multicenter study. Patients receive lurtotecan liposome
(NX211) IV over 30 minutes on days 1, 2, and 3. Courses are repeated every 3 weeks.
Treatment continues for up to 6 courses in the absence of unacceptable toxicity or disease
progression. The dose of NX211 is escalated in cohorts of 3-6 patients until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose limiting toxicity. Patients are followed at 4 weeks and every
3 months for 1 year.
PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-15
months.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced solid tumors
that are unresponsive to existing therapy and for which no curative therapy exists
Evidence of disease other than tumor marker elevation No untreated CNS metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST and ALT no
greater than 2.5 times ULN (no greater than 5 times ULN for liver metastases) Renal:
Creatinine no greater than upper limit of normal Cardiovascular: Not specified Pulmonary:
Not specified Other: No prior malignancy within past 5 years except curatively treated
basal or squamous cell skin cancer or carcinoma in situ of the cervix Not pregnant or
nursing Fertile patients must use effective contraception No active or uncontrolled
infection No other serious illness or medical condition No known hypersensitivity to
systemic liposomal formulation or any drug chemically related to study drug
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No greater than 3
prior chemotherapy regimens (adjuvant and metastatic) At least 3 weeks since prior
adjuvant and metastatic chemotherapy (6 weeks for nitrosoureas or mitomycin and 4 weeks
for carboplatin or other experimental anti cancer drugs) and recovered At least 1 year
since prior high dose chemotherapy with bone marrow or stem cell support No other
concurrent chemotherapy Endocrine therapy: Prior hormonal therapy allowed No concurrent
hormonal therapy Radiotherapy: No prior radiotherapy to greater than 25% of bone marrow At
least 4 weeks since prior radiotherapy, except for low dose myelosupressive radiotherapy,
and recovered Concurrent palliative radiotherapy allowed Surgery: Not specified Other: At
least 4 weeks since prior experimental drug or anticancer therapy No other concurrent
investigational or anticancer therapy
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Karen A. Gelmon, MD
Investigator Role:
Study Chair
Investigator Affiliation:
British Columbia Cancer Agency
Authority:
United States: Federal Government
Study ID:
I123
NCT ID:
NCT00003891
Start Date:
February 1999
Completion Date:
September 2009
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
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