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Breast CancerPhase 2NCT01009983

Paclitaxel, Carboplatin, and Panitumumab in Treating Patients With Metastatic Breast Cancer

A Phase 2 study testing panitumumab, paclitaxel and carboplatin in people with Breast Cancer and Recurrent Breast Cancer, run by Wake Forest University Health Sciences at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
panitumumab, paclitaxel and carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
2 sitesUnited States
Study dates
Mar 2010to Dec 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed invasive breast cancer with ER < 10%, PR < 10%, by IHC, HER2 1+ or 0 or FISH negative
  • Measurable (>= 1 cm) or assessable disease detectable by imagining or physical exam
  • Patients with bone only disease have measurable lesions on x-ray, MRI, or CT scan
  • Only one or no prior therapy for metastatic or recurrent breast cancer is allowed
  • Prior chemotherapy or radiation therapy is permitted but at least 2 weeks should elapse prior to study enrollment
  • Prior therapy with bevacizumab is permitted but at least 2 weeks should elapse prior to study enrollment
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  • Prior therapy with bevacizumab is permitted but at least 28 days should elapse from the last bevacizumab treatment prior to study enrollment
  • ECOG PS or 0-1
  • Signed protocol specific informed consent prior to registration
  • Life expectancy greater than 3 months
  • Please contact study investigator and/or consult the protocol document for specific laboratory criteria
  • Tissue block available from primary breast cancer
  • Premenopausal women must have a negative serum or urine pregnancy test prior to starting on study treatment (post-menopausal is defined as > 6 months of amenorrhea prior hysterectomy)

Who cannot join

  • More than or equal to 2 prior regimens for metastatic breast cancer
  • Leptomeningeal disease
  • Brain metastasis except for a solitary lesion that was resected or treated with gamma knife with no residual disease on CT or MRI or received whole brain RT and f/u MRI was normal with no residual neurologic deficit
  • History of interstitial lung disease (ie pneumonitis, pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan
  • History of irreversible neuropathy
  • Another malignancy other than carcinoma in situ of the cervix or skin cancer
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  • Active uncontrolled bacterial viral or fungal infection
  • Active pregnancy or breast feeding
  • Patients with pre-existing neuropathy >= grade 2
  • History of myocardial infarction, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
  • Patients with previous history of CTCAE grade >= 3 hypersensitivity to paclitaxel or Cremophor EL are not eligible

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70115

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Phase II Clinical Trial of Weekly Paclitaxel and Carboplatin in Combination With Panitumumab in Metastatic Breast Cancer Patients With Triple Negative Disease

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Other find tumor cells and help kill them or carry tumor-killing substances to them. Giving panitumumab together with paclitaxel and carboplatin may be a better way to block tumor growth.

PURPOSE: This phase II trial is studying the side effects and how well paclitaxel and carboplatin together with panitumumab works in treating patients with metastatic triple negative breast cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the response rate to the combination of carboplatin, paclitaxel and panitumumab in women with ER-, PR- and Her-2 negative metastatic breast cancer.

SECONDARY OBJECTIVES:

  1. To determine the tolerability and toxicities of the combination of paclitaxel, carboplatin and panitumumab.

II. To determine the markers that co-occur with EGFR expression in the triple negative breast cancer.

III. To assess the association between tumor biomarkers and clinical outcomes (response and survival).

IV. To examine the effect this regimen has on time to progression and survival.

OUTLINE:

Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Being tested
panitumumab, paclitaxel, carboplatin, laboratory biomarker analysis, immunohistochemistry staining method
Keywords
triple-negative breast cancer
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • panitumumabBiological

    Also called ABX-EGF, clone E7.6.3, MOAB ABX-EGF, monoclonal antibody ABX-EGF

    Given IV

  • paclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV

  • laboratory biomarker analysisProcedure or surgery

    Correlative study

  • immunohistochemistry staining methodProcedure or surgery

    Also called immunohistochemistry

    Correlative study

Study groups in NCT01009983
Study groupRoleWhat they receive
Arm 1ExperimentalPatients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
Receives: Biological: panitumumab; Drug: paclitaxel; Drug: carboplatin; Procedure: laboratory biomarker analysis; Procedure: immunohistochemistry staining method

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria

    Complete or Partial response as defined by reduction in tumor size according to RECIST (Response Evaluation Criteria In Solid Tumors) rules.

    Measured: every 28 days for a minimum of 84 days

Secondary outcomes (3)

  1. Time to Progression

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: Approximately 7 months

  2. Survival

    Measured: Approximately 7 months

  3. Expression of EGFR and Other Protein Markers

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2009 (estimated)
  2. Study startMar 2010
  3. Primary completionJul 2013
  4. Study completionDec 2013

Why it stopped: Slow accrual

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01009983
Sponsor's protocol ID
IRB00010510
Other IDs
NCI-2009-01257, CCCWFU74108
Status last verified
Jul 2018
First submitted
6 Nov 2009
Last updated
6 Jul 2018
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing panitumumab, paclitaxel and carboplatin in people with Breast Cancer and Recurrent Breast Cancer, run by Wake Forest University Health Sciences at 2 sites 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?

The sponsor lists 13 inclusion and 11 exclusion criteria. 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: stopped early, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria (time frame: every 28 days for a minimum of 84 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01009983.

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 6 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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