Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of soblidotin and gemcitabine in patients with
locally advanced or metastatic solid tumors.
- Determine the dose-limiting toxic effects of this regimen in these patients.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the antitumor activity of this regimen in these patients.
OUTLINE: This is an open-label, nonrandomized, multicenter, dose-escalation study.
Patients receive gemcitabine IV over 30 minutes and soblidotin IV over 1 hour on days 1 and
8. Courses repeat every 3 weeks in the absence of disease progression or unacceptable
toxicity.
Cohorts of 3-6 patients receive escalating doses of soblidotin and gemcitabine until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for survival every 3 months after completion of study therapy.
PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study within 1 year.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors
- Minimally pretreated
- Not refractory to prior gemcitabine therapy
- No disease progression during initial treatment with gemcitabine
- 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 at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases are
present)
Renal
- Creatinine no greater than 1.5 times ULN
Cardiovascular
- 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 study consent or compliance
- No concurrent severe or uncontrolled underlying medical disease unrelated to the
tumor that would compromise patient safety or affect study outcome
- No hypersensitivity to gemcitabine
- No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
unless in complete remission and off all therapy for that disease for at least 2
years
- No serious infection
- No grade 2 or greater neuropathy
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
- Recovered from prior radiotherapy
- No concurrent anticancer radiotherapy
- Concurrent localized palliative radiotherapy to a non-indicator lesion for pain
control allowed only if other methods of pain control are ineffective
Surgery
- At least 4 weeks since prior major surgery and recovered
Other
- More than 28 days since prior investigational drugs, including analgesics or
antiemetics
- At least 4 weeks since prior myelosuppressive therapy
- No other concurrent anticancer therapy
- No other concurrent anticancer cytotoxic therapy
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Robert L. DeJager, MD, FACP
Investigator Role:
Study Chair
Investigator Affiliation:
Daiichi Pharmaceuticals
Authority:
United States: Federal Government
Study ID:
CDR0000339345
NCT ID:
NCT00072228
Start Date:
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- Neoplasms
Name | Location |
|---|---|
| University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
