S0355 Ixabepilone in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
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| ClinicalTrials.gov Identifier: NCT00049400 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : April 3, 2015
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RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone in treating patients with advanced solid tumors or lymphomas and liver dysfunction.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific | Drug: BMS-247550 | Phase 1 |
OBJECTIVES:
- Determine the levels of hepatic impairment at which dose modifications of ixabepilone are required in patients with advanced solid tumors or lymphomas and varying levels of liver dysfunction.
- Determine the effect of hepatic dysfunction on the plasma pharmacokinetics of this drug in these patients.
- Determine the toxic effects of this drug at varying levels of hepatic dysfunction in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to liver function (normal vs mild dysfunction vs moderate dysfunction vs severe dysfunction).
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 6 but no more than 12 patients are treated at the recommended phase II dose.
Patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 12-84 patients (6-12 for stratum 1; 2-18 for stratum 2; 2-24 for stratum 3; and 2-30 for stratum 4) will be accrued for this study within 12 months.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 78 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I Pharmacokinetic Study Of Epothilone B Analogue BMS-247550 (NSC 710428D) In Patients With Advanced Malignancies And Varying Levels Of Liver Dysfunction |
| Study Start Date : | October 2003 |
| Actual Primary Completion Date : | September 2006 |
| Actual Study Completion Date : | December 2007 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: treatment
Single-arm, dose-escalation of BMS-247550
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Drug: BMS-247550
BMS-247550 as a 3-hour infusion on Day 1 of a three-week cycle |
- dose defining [ Time Frame: Treatment delays >2 weeks constitute a DLT ]
- Progression [ Time Frame: 30 days after going off study ]20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline.
- Symptomatic deterioration [ Time Frame: 30 days after going off study ]Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed solid tumor or lymphoma for which standard curative or palliative measures do not exist or are no longer effective
- Pathological confirmation of diagnosis not required in patients with liver mass, raised alpha-fetoprotein levels (at least 500 ng/mL), and positive serology for hepatitis consistent with a diagnosis of hepatocellular carcinoma
- Any solid tumor or lymphoma tumor type eligible
- Must have had thoracic and upper abdominal CT scan, including entire liver and adrenals, within 28 days before study entry
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Patients with glioma or brain metastases must be on a stable dose of corticosteroids and be seizure-free for the past month
- Prior whole brain or gamma knife radiotherapy required for known brain metastases
- No unstable or untreated (non-irradiated) brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No active hemolysis
Hepatic
- See Disease Characteristics
- Patients with biliary obstruction for which a shunt has been placed are allowed if shunt is in place for at least 10 days and liver function is stable
- Abnormal liver function (bilirubin and SGOT) allowed regardless of cause (metastases or other causes)
- No evidence of biliary sepsis
Renal
- Creatinine no greater than 1.5 mg/dL
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- No concurrent uncontrolled illness
- No ongoing or active infection
- No uncontrolled diarrhea
- No peripheral neuropathy grade II or greater
- No psychiatric illness or social situation that would preclude study compliance
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy for malignancy
Chemotherapy
- More than 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No other concurrent chemotherapy for malignancy
Endocrine therapy
- See Disease Characteristics
- No concurrent oral contraceptives
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No concurrent hormone therapy for malignancy
- Concurrent luteinizing hormone-releasing hormone agonists allowed
Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy for malignancy
Surgery
- More than 2 weeks since prior major surgery
Other
- Recovered from prior therapy
- No concurrent medications that are known to be inhibitors of CYP3A4
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049400
Show 23 study locations
| Principal Investigator: | Angela Davies, MD | University of California, Davis | |
| Principal Investigator: | Chris H. Takimoto, MD, PhD | Institute for Drug Development |
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00049400 |
| Other Study ID Numbers: |
S0355 U01CA076642 ( U.S. NIH Grant/Contract ) P30CA016087 ( U.S. NIH Grant/Contract ) S0355 ( Other Identifier: SWOG ) U10CA032102 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | April 3, 2015 |
| Last Verified: | April 2015 |
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unspecified adult solid tumor, protocol specific anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma intraocular lymphoma primary central nervous system lymphoma recurrent adult diffuse large cell lymphoma recurrent adult Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult T-cell leukemia/lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent grade 1, 2, or 3 follicular lymphoma recurrent mantle cell lymphoma small intestine lymphoma stage IV adult diffuse large cell or mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma |
stage IV adult Burkitt lymphoma or Hodgkin lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV adult T-cell leukemia/lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma stage IV grade 1, 2, or 3 follicular lymphoma stage IV mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma stage IV small lymphocytic lymphoma stage IV marginal zone lymphoma extranodal marginal zone B-cell lymphoma of MALT nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma recurrent adult Burkitt lymphoma |
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Lymphoma Intestinal Neoplasms Liver Diseases Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |