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Adult Solid NeoplasmPhase 1/2NCT00070252

Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer

A Phase 1/2 study testing Capecitabine, Docetaxel and Laboratory Biomarker Analysis in people with Adult Solid Neoplasm and Inflammatory Breast Carcinoma, run by National Cancer Institute (NCI) at 7 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

Phase I/II trial to study the effectiveness of neoadjuvant tipifarnib combined with docetaxel and capecitabine in treating patients who have locally advanced or metastatic solid tumors or stage IIIA or stage IIIB breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Capecitabine, Docetaxel and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
7 sitesUnited States
Study dates
Sep 2003to Jun 2010
Phase
Phase 1/2
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

  • Histologically or cytologically confirmed solid tumor
  • Locally advanced or metastatic
  • No known standard therapy that is potentially curative or definitely capable of extending life expectancy
  • No history of metastatic brain disease within the past 6 months
  • Treated metastatic brain disease is allowed provided disease has been stable for more than 6 months and does not require concurrent steroids or anti-seizure medication
  • Histologically confirmed breast cancer
Show all 62Show fewer
  • Stage IIIA or stage IIIB, including ipsilateral palpable supraclavicular lymph node(s) without other distant metastasis
  • Invasive disease confirmed by 1 of the following*:
  • Incisional biopsy
  • Punch biopsy (applicable for clinical T4b tumors)
  • Core needle (cutting needle) biopsies
  • No distant metastatic disease
  • Hormone receptor status:
  • Not specified
  • Male or female
  • Performance status - ECOG 0-1
  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10.0 g/dL
  • Bilirubin no greater than upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN
  • AST no greater than 2.5 times ULN
  • Creatinine no greater than 1.25 times ULN
  • Creatinine clearance at least 50 mL/min
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring antibiotics
  • No diabetes
  • No symptomatic neurologic condition
  • No other uncontrolled serious medical condition
  • No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No history of hypersensitivity to intravenous paclitaxel or other medication containing Cremophor EL or polysorbate 80 as a carrier (phase Ib)
  • Phase Ib only:
  • More than 4 weeks since prior immunotherapy
  • More than 4 weeks since prior biologic therapy
  • No concurrent immunotherapy
  • Phase Ib and II:
  • No concurrent prophylactic filgrastim (G-CSF)
  • Phase Ib only:
  • More than 1 year since prior adjuvant docetaxel before metastatic relapse
  • More than 4 weeks since prior chemotherapy and recovered
  • No prior capecitabine AND docetaxel (in combination or as single agents)
  • Prior capecitabine OR docetaxel allowed
  • No other concurrent chemotherapy
  • Phase II only:
  • No prior cytotoxic chemotherapy for breast cancer
  • Phase Ib only:
  • More than 3 weeks since prior radiotherapy
  • No prior radiotherapy to more than 25% of bone marrow
  • No concurrent radiotherapy
  • Phase II only:
  • No prior radiotherapy for breast cancer
  • Phase Ib only:
  • More than 4 weeks since prior major surgery
  • Phase II only:
  • No prior surgery (other than core or incisional biopsy for diagnostic purposes) for breast cancer
  • Phase Ib only:
  • No other ancillary investigational therapy
  • Phase Ib and II:
  • No concurrent sorivudine or brivudine

Who cannot join

None listed.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • University of Wisconsin Medical School

    Milwaukee, Wisconsin, 53201

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Howard University Cancer Center CCOP

    Washington D.C., District of Columbia, 20060

Other trials in United States

About this study

Official title: Phase Ib/II Neoadjuvant Trial of the Farnesyltransferase Inhibitor, R115777 With Docetaxel and Capecitabine for Patients With Stage IIIA or IIIB Breast Cancer

Phase I/II trial to study the effectiveness of neoadjuvant tipifarnib combined with docetaxel and capecitabine in treating patients who have locally advanced or metastatic solid tumors or stage IIIA or stage IIIB breast cancer. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy, such as docetaxel and capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining tipifarnib with docetaxel and capecitabine may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the maximum tolerated dose and recommended dose of capecitabine in combination with docetaxel and tipifarnib in patients with locally advanced or metastatic solid tumors. (Phase Ib) II. Determine the complete pathological and clinical response rate in patients with stage IIIA or IIIB breast cancer treated with this regimen. (Phase II)

SECONDARY OBJECTIVES:

  1. Determine the toxicity of this regimen in these patients. II. Determine disease-free and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of capecitabine. Patients in phase II are stratified according to type of breast cancer (inflammatory vs noninflammatory).

Phase Ib: Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14 and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Phase II: Patients receive oral tipifarnib twice daily for 6 days. Beginning at least 48 hours after completion of the initial dose of tipifarnib, patients receive treatment as in phase Ib for up to 6 courses at the MTD of capecitabine. Patients in phase Ib are followed at 3 months.

Patients in phase II are followed every 4 months for up to 5 years.

PROJECTED ACCRUAL: A total of 24-53 patients (9-18 for phase Ib and 15-35 for phase II) will be accrued for this study within 14-35 months.

Being tested
Capecitabine, Docetaxel, Laboratory Biomarker Analysis, Pharmacological Study, Tipifarnib
Medical subject headings
Inflammatory Breast Neoplasms, Breast Neoplasms, Male, Breast Neoplasms

What participants receive

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

  • CapecitabineDrug

    Also called Ro 09-1978/000, Xeloda

    Given PO

  • DocetaxelDrug

    Also called RP56976, Taxotere, Taxotere Injection Concentrate

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Pharmacological StudyOther

    Correlative studies

  • TipifarnibDrug

    Also called R115777, Zarnestra

    Given orally (PO)

Study groups in NCT00070252
Study groupRoleWhat they receive
Treatment (tipifarnib, capecitabine, docetaxel)ExperimentalPhase Ib: Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14 and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Phase II: Patients receive oral tipifarnib twice daily for 6 days. Beginning at least 48 hours after completion of the initial dose of tipifarnib, patients receive treatment as in phase Ib for up to 6 courses at the MTD of capecitabine.
Receives: Drug: Capecitabine; Drug: Docetaxel; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Tipifarnib

What is being measured

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

  1. Dose-limiting toxicity (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Phase I)

    Measured: 21 days

  2. Pathologic complete response rate (Phase II)

    Estimated by the number of patients with a complete pathologic response divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response probability will be calculated according to the approach of Duffy and Santner.

    Measured: Up to 5 years

Secondary outcomes (3)

  1. Clinical tumor response (complete response [CR] or partial response [PR]) (Phase I)

    Clinical responses will be summarized by simple descriptive summary statistics.

    Measured: Up to 5 years

  2. Overall survival

    The distribution of survival time will be estimated using the method of Kaplan-Meier.

    Measured: From registration to death due to any cause, assessed up to 5 years

  3. Toxicity as assessed by the National Cancer Institute (NCI) CTCAE version 3.0

    Measured: Up to 5 years

Timeline

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

  1. First posted7 Oct 2003 (estimated)
  2. Study startSep 2003
  3. Primary completionFeb 2006
  4. Study completionJun 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00070252
Sponsor's protocol ID
NCI-2012-01442
Other IDs
NCI-2012-01442, WSU-C-2679, MAYO-MC0131, NCI-5599, CDR0000331694, MC0131, 5599, N01CM62205
Status last verified
Dec 2012
First submitted
3 Oct 2003
Last updated
4 May 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Capecitabine, Docetaxel and Laboratory Biomarker Analysis in people with Adult Solid Neoplasm and Inflammatory Breast Carcinoma, run by National Cancer Institute (NCI) at 7 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 62 inclusion and 0 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 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 combined 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.

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?

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?

Dose-limiting toxicity (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Phase I) (time frame: 21 days). The study lists 2 primary outcomes in all. 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 NCT00070252.

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 4 May 2015.

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