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Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
First Received: October 4, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
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: Treatment
Official Title: Phase I Trial of Combination Pegylated Liposomal Doxorubicin (Doxil), Vinorelbine, and Gemcitabine

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2000
Detailed Description:

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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006372

Locations
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5055
Sponsors and Collaborators
Ireland Cancer Center
Investigators
Study Chair: Beth A. Overmoyer, MD, FACP Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068245, CWRU-1Y99, NCI-G00-1859
Study First Received: October 4, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006372     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Antimetabolites
Immunologic Factors
Vinblastine
Antimitotic Agents
Antiviral Agents
Immunosuppressive Agents
Doxorubicin
Anti-Bacterial Agents
Vinorelbine
Radiation-Sensitizing Agents
Tubulin Modulators
Gemcitabine
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors
Vinblastine
Antimitotic Agents
Antibiotics, Antineoplastic
Immunosuppressive Agents
Antiviral Agents
Doxorubicin
Pharmacologic Actions
Vinorelbine
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Gemcitabine
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 02, 2009