Soblidotin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors
RATIONALE: Drugs used in chemotherapy, such as soblidotin and gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of soblidotin and gemcitabine in treating patients with locally advanced or metastatic solid tumors.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
New Mexico
-
Albuquerque, New Mexico, Förenta staterna, 87131-5636
- University of New Mexico Cancer Research and Treatment Center
-
-
New York
-
New York, New York, Förenta staterna, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Robert L. DeJager, MD, FACP, Daiichi Pharmaceuticals
Studieavstämningsdatum
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DAIICHI-1027A-PRT008
- CDR0000339345 (Registeridentifierare: PDQ (Physician Data Query))
- CPMC-IRB-20031085
- NCT00072228
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