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AzTrials

Breast CancerPhase 1NCT00680758

Cisplatin, Paclitaxel, and Everolimus in Treating Patients With Metastatic Breast Cancer

A Phase 1 study testing cisplatin, everolimus and paclitaxel in people with Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus 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
What is being tested?
cisplatin, everolimus and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
4 sitesUnited States
Study dates
May 2008to Dec 2010
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

Who may be able to join

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed invasive mammary carcinoma
  • Stage IV disease
  • No locally recurrent breast cancer
  • Patients with HER2/neu overexpressing tumors must have received prior trastuzumab (Herceptin®) in first-line treatment of metastatic breast cancer
  • Patients with estrogen receptor- or progesterone receptor-expressing tumors must have received prior endocrine therapy (i.e., aromatase inhibitors, fulvestrant, tamoxifen, or ovarian ablation) in first-line treatment of metastatic breast cancer
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  • No symptomatic brain metastases
  • Patients with a history of brain metastases must be clinically stable and not taking steroids or therapeutic anticonvulsants that are CYP3A4 modifiers
  • Patients with asymptomatic brain metastases on prophylactic convulsants that are CYP3A4 modifiers are not eligible
  • Hormone receptor status not specified
  • PATIENT CHARACTERISTICS:
  • Menopausal status not specified
  • ECOG performance status 0-1
  • Life expectancy ≥ 6 months
  • ANC ≥ 1000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN (3 times ULN if liver metastasis present)
  • SGOT and SGPT ≤ 1.5 times ULN (3 times ULN if liver metastasis present)
  • Alkaline phosphatase ≤ 3 times ULN if liver metastasis present
  • Able to swallow and retain oral medication
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • Must be disease-free from prior invasive cancers for > 5 years with the exception of completely resected basal cell or squamous cell carcinoma of the skin or successfully treated cervical carcinoma in situ
  • No malabsorption syndrome, disease significantly affecting gastrointestinal function, or ulcerative colitis
  • No uncontrolled intercurrent illness including, but not limited to:
  • Ongoing or active infection requiring parenteral antibiotics
  • Impairment of lung function (i.e., chronic obstructive pulmonary disease or lung conditions requiring oxygen therapy)
  • Symptomatic New York Heart Association class III-IV congestive heart failure
  • Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within the past 6 months
  • Uncontrolled hypertension (systolic blood pressure [BP] > 180 mm Hg or diastolic BP > 100 mm Hg)
  • Clinically significant cardiac arrhythmia (i.e., multifocal premature ventricular contractions, bigeminy, trigeminy, or ventricular tachycardia that is symptomatic or requires treatment)
  • Uncontrolled diabetes
  • Psychiatric illness/social situations that would preclude compliance with study requirements
  • No known history of uncontrolled or symptomatic neuropathy ≥ grade 2
  • No hypersensitivity to paclitaxel, or drugs using the vehicle Cremophor, Chinese hamster ovary cell products, or other recombinant human antibodies

Who cannot join

  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Recovered from all prior treatment
  • Must not have exceeded a total cumulative dose of life-time exposure of doxorubicin hydrochloride ≤ 360 mg/m² or epirubicin hydrochloride ≤ 640 mg/m²
  • At least 2 weeks since other prior investigational drugs
  • No prior resection of the stomach or small bowel
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  • No more than 4 prior chemotherapy regimens in the metastatic setting
  • This restriction does not include endocrine therapies or single agent biologic therapies (i.e., trastuzumab)
  • Concurrent radiotherapy to painful bone metastases or areas of impending bone fracture allowed as long as radiotherapy is initiated prior to study entry
  • No concurrent trastuzumab
  • No concurrent endocrine therapy
  • No concurrent CYP3A4 modifiers
  • No concurrent herbal supplement
  • No other concurrent anticancer therapy (chemotherapy, radiotherapy, surgery, immunotherapy, hormonal therapy, or biological therapy)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Vanderbilt-Ingram Cancer Center - Cool Springs

    Nashville, Tennessee, 37064

  • Vanderbilt-Ingram Cancer Center at Franklin

    Nashville, Tennessee, 37064

  • Sarah Cannon Cancer Center at Centennial Medical Center

    Nashville, Tennessee, 37203

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

Other trials in United States

About this study

Official title: A Phase I Study of Cisplatin, Paclitaxel, and RAD001 Patients With Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) together with everolimus may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of cisplatin, paclitaxel, and everolimus when given together for the treatment of patients with metastatic breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To establish the safety profile and the maximum tolerated dose of the combination of cisplatin, paclitaxel, and everolimus in patients with metastatic breast cancer.

Secondary

  • To explore the antitumor activity of this regimen, in terms of response rate and time to progression in these patients.

OUTLINE: This is a multicenter study.

Patients receive cisplatin intravenously (IV) over 1 hour and paclitaxel IV over 1 hour on days 1, 8, and 15. Patients receive oral everolimus on days 1, 8, 15, and 21. Courses repeat every 4 weeks in the absence of disease progression and unaccepted toxicity.

After completion of study therapy, patients are followed at 4 weeks.

Conditions
Breast Cancer
Keywords
male breast cancer, stage IV breast cancer
Medical subject headings
Breast Neoplasms, Breast Neoplasms, Male

What participants receive

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

  • cisplatinDrug

    Also called Platinol

    • Dose Level: -3 20mg/m2/week 3-6 patients
    • Dose Level: -2 20mg/m2/week 3-6 patients
    • Dose Level: -1 25mg/m2/week 3-6 patients
    • Dose Level: 1 25mg/m2/week 3-6 patients
    • Dose Level: 2 25mg/m2/week 3-6 patients
    • Dose Level: 3 25mg/m2/week 3-6 patients

  • everolimusDrug

    Also called RAD001

    • Dose Level: -3 20mg/m2/week 3-6 patients
    • Dose Level: -2 20mg/m2/week 3-6 patients
    • Dose Level: -1 20mg/m2/week 3-6 patients
    • Dose Level: 1 20mg/m2/week 3-6 patients
    • Dose Level: 2 25mg/m2/week 3-6 patients
    • Dose Level: 3 30mg/m2/week 3-6 patients

  • paclitaxelDrug

    Also called Taxol

    • Dose Level: -3 65mg/m2/week 3-6 patients
    • Dose Level: -2 70mg/m2/week 3-6 patients
    • Dose Level: -1 70mg/m2/week 3-6 patients
    • Dose Level: 1 80mg/m2/week 3-6 patients
    • Dose Level: 2 80mg/m2/week 3-6 patients
    • Dose Level: 3 80mg/m2/week 3-6 patients
Study groups in NCT00680758
Study groupRoleWhat they receive
Therapeutic InterventionExperimentalNot described
Receives: Drug: cisplatin; Drug: everolimus; Drug: paclitaxel

What is being measured

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

  1. Safety profile and maximum tolerated dose

    The Maximum Tolerated Dose (MTD) will be the dose level at which fewer than 2 of 6 (or 33% of) patients experience dose limiting toxicity (DLT).

    Measured: At 4 weeks

Secondary outcomes (3)

  1. Antitumor activity

    Cisplatin + Paclitaxel + RAD001 combination by determining response rates (RR) and time to progression (TTP) achieved with treatment

    Measured: Date of study entry to date of progression of disease

  2. Response rate

    Measured: at baseline and every 8 weeks to disease progression

  3. Time to progression

    Measured: date of study entry to date of disease progression

Timeline

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

  1. First posted20 May 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionAug 2009
  4. Study completionDec 2010

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00680758
Sponsor's protocol ID
VICC BRE 0770
Other IDs
VU-VICC-BRE-0770
Status last verified
Mar 2013
First submitted
18 May 2008
Last updated
8 Mar 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cisplatin, everolimus and paclitaxel in people with Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 4 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 37 inclusion and 14 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: finished, as of the sponsor's last update on 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 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?

Safety profile and maximum tolerated dose (time frame: At 4 weeks). 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 NCT00680758.

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 8 Mar 2013.

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