Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
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Purpose
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 combination chemotherapy in treating patients who have advanced solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: gemcitabine hydrochloride Drug: pegylated liposomal doxorubicin hydrochloride Drug: vinorelbine ditartrate |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Trial of Combination Pegylated Liposomal Doxorubicin (Doxil), Vinorelbine, and Gemcitabine |
| Enrollment: | 10 |
| Study Start Date: | February 2000 |
| Study Completion Date: | February 2005 |
| Primary Completion Date: | April 2003 (Final data collection date for primary outcome measure) |
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Drug: gemcitabine hydrochloride
OBJECTIVES:
- Determine the pharmacokinetic profile of gemcitabine, doxorubicin HCl liposome, and vinorelbine in patients with advanced solid tumors.
- Determine the maximum tolerated dose of this regimen in these patients.
- Determine the toxicity profile of this regimen in these patients.
OUTLINE: This is a dose escalation study.
Patients receive doxorubicin HCl liposome IV over 1-2.5 hours on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and vinorelbine IV over 6-10 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome, gemcitabine, and vinorelbine 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 every 3 months for up to 1 year.
PROJECTED ACCRUAL: Approximately 9-24 patients will be accrued for this study within 12-18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed solid tumor not amenable to curative surgery, radiotherapy, or chemotherapy
- No brain metastases or primary brain tumors
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- WBC at least 3,500/mm3
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin greater than 10 g/dL
Hepatic:
- Bilirubin no greater than 1.2 mg/dL
- AST and/or ALT less than 2.5 times upper limit of normal (ULN)
- PT no greater than ULN (anticoagulant independent)
Renal:
- Creatinine no greater than 1.5 mg/dL AND/OR
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No New York Heart Association class III or IV heart disease
- LVEF at least 45% by MUGA or echocardiogram
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior bone marrow or peripheral blood stem cell transplantation following high dose chemotherapy
- At least 3 weeks since prior biologic therapy for cancer and recovered
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy:
- See Disease Characteristics
- See Biologic therapy
- No more than 1 prior chemotherapy regimen
- No prior vinca alkaloids
- Prior anthracycline allowed if total dose no greater than 300 mg/m2
- At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or carmustine) and recovered
Endocrine therapy:
- At least 3 weeks since prior endocrine therapy for cancer and recovered
Radiotherapy:
- See Disease Characteristics
- No more than 1 prior radiotherapy regimen
- At least 4 weeks since prior large field radiotherapy
- At least 3 weeks since prior radiotherapy for cancer and recovered
Surgery:
- Not specified
Contacts and Locations| United States, Ohio | |
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5055 | |
| Study Chair: | Beth A. Overmoyer, MD, FACP | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Beth A. Overmoyer, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00006372 History of Changes |
| Other Study ID Numbers: | CWRU1Y99, P30CA043703, CWRU-1Y99, NCI-G00-1859 |
| Study First Received: | October 4, 2000 |
| Last Updated: | June 9, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Case Comprehensive Cancer Center:
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms Doxorubicin Gemcitabine Vinorelbine Vinblastine Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |
ClinicalTrials.gov processed this record on May 16, 2013