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Trial record 1 of 1 for:    NCT00667641
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Paclitaxel and Bortezomib in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors

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ClinicalTrials.gov Identifier: NCT00667641
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : May 10, 2011
National Cancer Institute (NCI)
Information provided by:
Rutgers, The State University of New Jersey

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel together with bortezomib may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of paclitaxel and bortezomib in treating patients with metastatic or unresectable malignant solid tumors.

Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Head and Neck Cancer Lung Cancer Melanoma (Skin) Ovarian Cancer Pancreatic Cancer Prostate Cancer Unspecified Adult Solid Tumor, Protocol Specific Drug: bortezomib Drug: paclitaxel Phase 1

Detailed Description:



  • To identify the maximum tolerated dose of paclitaxel in combination with bortezomib in patients with metastatic or unresectable solid tumor malignancies that involve an activated Ras/Raf/MAPK pathway.


  • To assess the toxicity of this regimen.
  • To assess tumor response in these patients.
  • To determine whether Bim is upregulated in peripheral blood mononuclear cells obtained from patients treated with this regimen.
  • To correlate markers of Ras/Raf/MAPK pathway activation in fresh or archived tumor tissue with clinical response in these patients.
  • To perform pharmacokinetic (PK) studies to determine whether bortezomib alters paclitaxel PK parameters.

OUTLINE: Patients receive paclitaxel IV over 1 hour and bortezomib IV on days 1, 8, and 15. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and periodically during course 1 for pharmacokinetic and biomarker studies. Blood samples are analyzed for plasma concentrations of paclitaxel by high performance liquid chromatography and for Bim protein levels and phosphorylation status by western blotting. Tumor tissue samples, if available, are analyzed to evaluate the presence of an activated Ras/Raf/MAPK pathway. Tumor tissue samples are analyzed for Ras and/or Raf mutations by nucleic acid extraction and direct sequencing; Ras and/or Raf overexpression by western blotting; Ras activation assay; and/or phospho-ERK by western blotting and IHC.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Paclitaxel (Taxol) and Bortezomib (Velcade) in Patients With Refractory Solid Tumor Malignancies Involving an Activated MAPK Pathway
Study Start Date : March 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Intervention Details:
  • Drug: bortezomib
    Starting dose level 0.70mg/m2
  • Drug: paclitaxel
    Starting dose level 40mg/m2

Primary Outcome Measures :
  1. Maximum tolerated dose of paclitaxel in combination with bortezomib [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed malignant solid tumor that involves an activated Ras/Raf/MAPK pathway, including the following:

    • Breast cancer
    • Prostate cancer
    • Colon cancer
    • Pancreatic cancer
    • Ovarian cancer
    • Non-small cell lung cancer
    • Melanoma
    • Papillary thyroid cancer
  • Metastatic or unresectable disease
  • Standard curative or palliative measures do not exist or are no longer effective
  • No newly diagnosed, untreated, or uncontrolled brain metastases


  • ECOG performance status 0-2
  • ANC ≥ 1,500/μL
  • WBC ≥ 3,500/μL
  • Platelet count ≥ 100,000/μL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST/ALT ≤ 2.5 times ULN (≤ 5 times ULN for tumor involvement of the liver)
  • Creatinine ≤ 2 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No neuropathy ≥ grade 1 with pain within the past 14 days
  • No active infections
  • No myocardial infarction within the past 6 months
  • No NYHA class III or IV heart failure
  • No uncontrolled angina
  • No severe uncontrolled ventricular arrhythmias
  • No evidence of acute ischemia or active conduction system abnormalities by ECG

    • Any ECG abnormality at screening must be documented by the investigator as not medically relevant
  • No hypersensitivity to bortezomib, boron, or mannitol
  • No serious medical or psychiatric illness likely to interfere with study participation


  • Prior paclitaxel or bortezomib allowed
  • At least 4 weeks since prior chemotherapy and/or radiotherapy
  • More than 14 days since other prior investigational drugs
  • No other concurrent investigational agents
  • No other concurrent anticancer agents, including chemotherapy and biologic agents
  • No concurrent recombinant interleukin-11 (Neumega®)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667641

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United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
National Cancer Institute (NCI)
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Principal Investigator: Vassil Karantza-Wadsworth, MD Rutgers Cancer Institute of New Jersey
Additional Information:
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Responsible Party: Vassiliki Karantza-Wadsworth, MD, PhD, UMDNJ/CINJ
ClinicalTrials.gov Identifier: NCT00667641    
Other Study ID Numbers: CDR0000592905
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: May 10, 2011
Last Verified: May 2011
Keywords provided by Rutgers, The State University of New Jersey:
unspecified adult solid tumor, protocol specific
recurrent breast cancer
stage IV breast cancer
recurrent prostate cancer
stage IV prostate cancer
recurrent colon cancer
stage IV colon cancer
recurrent pancreatic cancer
stage IV pancreatic cancer
recurrent ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian germ cell tumor
stage IV ovarian germ cell tumor
recurrent non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent melanoma
stage IV melanoma
stage IV papillary thyroid cancer
recurrent thyroid cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Pancreatic Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Diseases
Digestive System Neoplasms
Digestive System Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents, Phytogenic