Clinical trial NCT00003359: T138067 Sodium in Treating Patients With Advanced Refractory Cancer
Official title: Phase I Dose Escalation Study to Evaluate the Safety of T138067-Sodium in Patients With Advanced Refractory Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-07-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of T138067 sodium in treating patients with advanced refractory cancer.

Detailed description: OBJECTIVES: I. Determine the maximum tolerated dose of T138067 sodium that can be given to patients with advanced refractory cancer on a 28-day schedule and establish a dose for further study. II. Evaluate the safety and dose limiting toxicity of T138067 sodium in these patients. III. Determine the pharmacokinetic parameters after a single intravenous dose of this agent in these patients. IV. Obtain safety data and preliminary efficacy information after repetition of single doses of T138067 sodium in these patients.

OUTLINE: This is an open label, dose escalation study. Patients receive T138067 sodium by IV over 3 hours. Patients may be retreated every 4 weeks for up to 6 courses (6 months total) in the absence of disease progression or dose limiting toxicity (DLT). At least 3 patients are treated at each dose level in the absence of DLT. The maximum tolerated dose is defined as the dose level where 2 of 3-6 patients experience DLT.

PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued into this study.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically confirmed advanced refractory cancer Must meet one of the following criteria: - Failed at least 1 regimen of radiotherapy, chemotherapy, or immunotherapy and not a candidate for a regimen of higher efficacy - Refractory to existing standard therapy and not candidate for a regimen of higher efficacy - Advanced malignancy for which there is no standard chemotherapy available No known brain metastases or leptomeningeal involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Prothrombin time at least 30% of control Partial thromboplastin time at least 30% of control Hepatic: Bilirubin less than 2 mg/dL ALT and AST no greater than 2 times normal Alkaline phosphatase no greater than 2 times normal Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No New York Heart Association class III or IV heart disease No myocardial infarction in the past 6 months Other: No immunodeficiency syndrome (acquired or congenital) No uncontrolled infection No significant comorbidity that may compromise participation in this study Not pregnant Effective contraception required of all fertile patients during and until 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks since prior immunotherapy No concurrent immunotherapy or biologic response modifier therapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: At least 3 weeks since any prior major surgery Other: No organ allograft At least 30 days since any prior investigational agents No concurrent nonsteroidal antiinflammatory agents or aspirin No concurrent alternative therapies (i.e., herbal medicines, high doses of vitamins) No other concurrent investigational agents

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: David R. Spriggs, MD
role: STUDY_CHAIR
References:
citation: Jahan TM, Sandler A, Burris H, et al.: A phase II study of T138067-sodium in prior taxane-treated patients (pts) with locally advanced or metastatic non-small cell lung cancer (NSCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1282, 2002.