NCT00667641

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 breast-cancer

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

May 10, 2011

Status Verified

May 1, 2011

Enrollment Period

1.9 years

First QC Date

April 25, 2008

Last Update Submit

May 9, 2011

Conditions

Breast CancerColorectal CancerHead and Neck CancerLung CancerMelanoma (Skin)Ovarian CancerPancreatic CancerProstate CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificrecurrent breast cancerstage IV breast cancerrecurrent prostate cancerstage IV prostate cancerrecurrent colon cancerstage IV colon cancerrecurrent pancreatic cancerstage IV pancreatic cancerrecurrent ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian germ cell tumorstage IV ovarian germ cell tumorrecurrent non-small cell lung cancerstage IV non-small cell lung cancerrecurrent melanomastage IV melanomastage IV papillary thyroid cancerrecurrent thyroid cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose of paclitaxel in combination with bortezomib

    2 years

Interventions

bortezomibDRUG

Starting dose level 0.70mg/m2

paclitaxelDRUG

Starting dose level 40mg/m2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: * 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 CONCURRENT THERAPY: * 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®)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsHead and Neck NeoplasmsLung NeoplasmsMelanomaOvarian NeoplasmsPancreatic NeoplasmsProstatic NeoplasmsColonic NeoplasmsCarcinoma, Ovarian EpithelialCarcinoma, Non-Small-Cell LungThyroid Cancer, PapillaryThyroid Neoplasms

Interventions

BortezomibPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinoma, PapillaryAdenocarcinomaThyroid Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Vassil Karantza-Wadsworth, MD

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2008

First Posted

April 28, 2008

Study Start

March 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

May 10, 2011

Record last verified: 2011-05

Locations

US(1)