Breast CancerPhase 1NCT00667641
Paclitaxel and Bortezomib in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors
A Phase 1 study testing bortezomib and paclitaxel in people with Breast Cancer and Colorectal Cancer, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Head and Neck Cancer
- What is being tested?
- bortezomib and paclitaxel
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Feb 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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®)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
About this study
Official title: Phase I Study of Paclitaxel (Taxol) and Bortezomib (Velcade) in Patients With Refractory Solid Tumor Malignancies Involving an Activated MAPK Pathway
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.
Read the detailed description
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
- Conditions
- Breast Cancer, Colorectal Cancer, Head and Neck Cancer, Lung Cancer, Melanoma (Skin), Ovarian Cancer
- Being tested
- bortezomib, paclitaxel
- Keywords
- 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
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Melanoma, Ovarian Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
Starting dose level 0.70mg/m2
paclitaxelDrug
Starting dose level 40mg/m2
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of paclitaxel in combination with bortezomib
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startMar 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Vassil Karantza-Wadsworth, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667641
- Sponsor's protocol ID
- CDR0000592905
- Other IDs
- P30CA072720, CINJ-050608, MILLENNIUM-CINJ-050608, CINJ-IRB-0220060270
- Status last verified
- May 2011
- First submitted
- 25 Apr 2008
- Last updated
- 10 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Paclitaxel (Taxol) and Bortezomib (Velcade) in Patients With Refractory Solid Tumor Malignancies Involving an Activated MAPK Pathway
- ClinicalTrials.gov ID
- NCT00667641
- Acronym / sponsor ID
- CDR0000592905
- Conditions
- Breast Cancer, Colorectal Cancer, Head and Neck Cancer, Lung Cancer, Melanoma (Skin), Ovarian Cancer
- Keywords
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 28 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bortezomibStarting dose level 0.70mg/m2 | Drug | – |
| paclitaxelStarting dose level 40mg/m2 | Drug | – |
Primary outcome
Maximum tolerated dose of paclitaxel in combination with bortezomib
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2011.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vassil Karantza-Wadsworth, MD principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bortezomib and paclitaxel in people with Breast Cancer and Colorectal Cancer, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of paclitaxel in combination with bortezomib (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2011.