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Phase I Trial of Combination Pegylated Liposomal Doxorubicin (Doxil), Vinorelbine, and Gemcitabine


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Trial of Combination Pegylated Liposomal Doxorubicin (Doxil), Vinorelbine, and Gemcitabine


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Beth A. Overmoyer, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU1Y99

NCT ID:

NCT00006372

Start Date:

February 2000

Completion Date:

February 2005

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065