|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Case Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00006372 |
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 I |
| 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) |
OBJECTIVES:
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:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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
| 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 |
|
unspecified adult solid tumor, protocol specific |
|
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 |