Adjuvant Therapy for High-Risk Breast Cancer With Wkly Adriamycin & Oral Cytoxan With G-CSF for 12 Wks; Wkly Taxol x 12

This study has been completed.
Sponsor:
Collaborators:
Amgen
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00194753
First received: September 14, 2005
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

The primary objectives of the study are to evaluate the feasibility and toxicity of treatment with 12 weeks of Adriamycin with daily oral Cytoxan with G-CSF support followed by 12 weeks of Taxol. Feasibility will be assessed by comparing the delivered dose intensity of each drug to the delivered dose intensity in previous trials. Toxicity will be assessed by comparing the incidence and severity of toxicity with these drugs to previous trials using these drugs in the same combination. We hypothesize metronomic, dose dense treatment as given in this study will be less toxic and more effective than historical regimens using the same drugs in a less metronomic, dose dense manner.


Condition Intervention Phase
Breast Neoplasm
Drug: Paclitaxel
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: G-CSF
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant Therapy for High-Risk Localized Breast Cancer With Weekly Adriamycin +/- Oral Cytoxan With Continuous G-CSF Support for 12 Weeks Followed by Weekly Taxol for 12 Weeks, Phase II

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Delivered dose intensity [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to treatment failure [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: December 2001
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Weekly doxorubicin (24 mg/m2 IV) with daily oral cyclophosphamide (60 mg/m2 PO) for 12 weeks with G-CSF support days 2 - 7 of each week followed by weekly paclitaxel (80 mg/m2 IV) for 12 weeks.
Drug: Paclitaxel
80 mg/m2 IV for 12 weeks following completion of doxorubicin and cyclophosphamide
Drug: Doxorubicin
24 mg/m2 IV weekly x 12
Drug: Cyclophosphamide
60 mg/m2 PO daily for 12 weeks
Drug: G-CSF
5 mcg per kg subcutaneously days 2 - 7 during doxorubicin and cyclophosphamide for 12 weeks

Detailed Description:

The systemic cancer treatments used in this study (Adriamycin, Cytoxan and Taxol) are all delivered in a dose dense, metronomic manner (weekly or daily). It is our hypothesis that dose dense treatment will result in optimum delivered dose intensity while minimizing toxicity. We will test these hypotheses by comparing the delivered dose intensity of the drugs to the delivered dose intensity of standard regimens. We will also compare time to relapse, survival and toxicity of this treatment to historic, standard regimens.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must have a histologically confirmed diagnosis of primary breast carcinoma that has been surgically resected. (This regimen is not intended for neoadjuvant treatment.)
  • The attending physician must judge the patient to be an appropriate candidate for Adriamycin based adjuvant chemotherapy. Appropriate candidates generally include those with stage II or III breast cancer. The individual attending physician, however, should make the decision.
  • Tumor HER-2/neu expression must be determined prior to study enrollment. Assessment may be by fluorescence in situ hybridization (FISH) assay or by immunocytochemistry (ICC). If determination is "intermediate" by immunocytochemistry, FISH must be performed. Protocol therapy is determined by HER-2/neu result.
  • Patient must be at least 18.
  • The patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
  • Pre-study hematologic values required for entry onto trial are: WBC greater than= 4,000/mm3, ANC greater than= 1,500/mm3 and platelets greater than= 100,000/mm3.

Exclusion Criteria:

  • Patients with significant renal dysfunction (creatinine greater than 1.5 x institutional upper limit of normal (IULN)) or hepatic dysfunction (bilirubin greater than IULN; transaminases greater than 2.5 x IULN) are not eligible.
  • Except for the following, no prior malignancy is allowed: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient has been disease free for 5 years.
  • Patients with clinically apparent cardiac disease, or history of same, are not eligible. Patients who are > 60 years of age or who have a history of hypertension must have a MUGA prior to enrollment. LVEF must be normal.
  • Patients who have received prior chemotherapy or radiotherapy are not eligible.
  • Patients who are pregnant or breastfeeding are not eligible. Women of child bearing potential must have a serum pregnancy test that is negative and agree to practice adequate contraception.
  • Patients with active infection are not eligible.
  • Patients who are known to be infected with HIV, hepatitis B or hepatitis C are not eligible. Testing is not required unless there is a high index of clinical suspicion.
  • Patients suffering from psychiatric impairment are not eligible.
  • Patients with known hypersensitivity to trimethoprim or sulfonamides are not eligible.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194753

Locations
United States, Washington
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
University of Washington
Amgen
Bristol-Myers Squibb
Investigators
Principal Investigator: Georgiana K. Ellis, M.D. University of Washington
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00194753     History of Changes
Other Study ID Numbers: 18229-A, 00-5889-A 07
Study First Received: September 14, 2005
Last Updated: September 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 28, 2014