Clinical trial · Interventional
BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors
A Phase I Trial of BMS 247550 (NSC# 710428) and Gemcitabine in Patients With Advanced Solid Tumor Malignancies
NCT00043095CI-TRIAL-00001597completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy 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: Phase I trial to study the effectiveness of combining BMS-247550 with gemcitabine in treating patients who have advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| ixabepilone | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-hematological cancer that is unresponsive to currently available therapies or for which there is no known effective treatment * Clinical or radiological evidence of disease required * No active brain metastases, including evidence of cerebral edema (by CT scan or MRI), progression from prior imaging study, any requirement for steroids, or clinical symptoms PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin at least 8.0 g/dL Hepatic * Bilirubin no greater than 1.5 mg/dL * ALT and AST no greater than 2.5 times upper limit of normal (ULN) or 93 U/L Renal * Creatinine no greater than 1.5 times ULN or 2.0 mg/dL Other * No documented hypersensitivity reaction to prior paclitaxel or other therapy containing Cremophor EL * No grade 2 or greater pre-existing peripheral neuropathy * No serious uncontrolled medical disorder or active infection that would preclude study therapy * No dementia or altered mental status that would preclude informed consent * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * At least 4 weeks since prior immunotherapy Chemotherapy * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or doxorubicin HCl liposome) * Prior taxanes allowed * Prior adjuvant or neoadjuvant chemotherapy allowed * No more than 2 prior chemotherapy regimens in the metastatic setting * No other concurrent chemotherapy Endocrine therapy * See Disease Characteristics * No concurrent hormonal therapy except hormone-replacement therapy * Concurrent medications to maintain castrate status for progressive hormone-refractory prostate cancer allowed Radiotherapy * At least 4 weeks since prior radiotherapy * No prior radiotherapy to more than 25% of bone marrow * No concurrent radiotherapy Surgery * Not specified Other * At least 4 weeks since prior investigational agents * No other concurrent experimental anticancer medications * No concurrent alternative therapies (e.g., high-dose vitamins or herbal medicines) * No concurrent combination antiretroviral therapy for HIV-positive patients
References
Publications (0)
Data not yet available
No reference posted for this study.