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Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00006372
First received: October 4, 2000
Last updated: June 9, 2010
Last verified: June 2010
  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

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

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)
Intervention Details:
    Drug: gemcitabine hydrochloride
    Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
    Drug: pegylated liposomal doxorubicin hydrochloride
    Patients receive doxorubicin HCl liposome IV over 1-2.5 hours on day 1. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
    Drug: vinorelbine ditartrate
    Patients receive 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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5055
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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:
Doxorubicin
Gemcitabine
Liposomal doxorubicin
Vinorelbine
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014