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CompletedNCT00070252Updated May 4, 2015

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 interventional study of Capecitabine and Docetaxel in Adult Solid Neoplasm, Inflammatory Breast Carcinoma and Male Breast Carcinoma, sponsored by National Cancer Institute (NCI). Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-04.

Sponsored by National Cancer Institute (NCI) · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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:

I. 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:

I. 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.

02

Conditions studied

  • Adult Solid Neoplasm
  • Inflammatory Breast Carcinoma
  • Male Breast Carcinoma
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 53 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • 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

    • 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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Treatment (tipifarnib, capecitabine, docetaxel)

    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. 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.

    Drug: Capecitabine · Drug: Docetaxel · Other: Laboratory Biomarker Analysis · Other: Pharmacological Study · Drug: Tipifarnib

Interventions

  • DrugCapecitabine

    Given PO

    Also known as: Ro 09-1978/000, Xeloda

  • DrugDocetaxel

    Given IV

    Also known as: RP56976, Taxotere, Taxotere Injection Concentrate

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • OtherPharmacological Study

    Correlative studies

  • DrugTipifarnib

    Given orally (PO)

    Also known as: R115777, Zarnestra

06

What researchers measure

Primary outcomes

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

    Time frame: 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.

    Time frame: Up to 5 years

Secondary outcomes

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

    Clinical responses will be summarized by simple descriptive summary statistics.

    Time frame: Up to 5 years

  2. Overall survival

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

    Time frame: 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

    Time frame: Up to 5 years

07

Study locations

7 sites
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
  • Howard University Cancer Center CCOP
    Washington, District of Columbia 20060, United States
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224-9980, United States
  • Barbara Ann Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • University of Wisconsin Medical School
    Milwaukee, Wisconsin 53201, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00070252
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 7, 2003
Start date
Sep 2003
Primary completion
Feb 2006
Completion
Jun 2010
Last update
May 4, 2015

Study contacts

Philip Philip
principal investigator · Mayo Clinic
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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