NCT00007904|CompletedPhase 2DMC

Adjuvant Stage 2-3A Breast Cancer With Positive Lymph Nodes

A Phase II Study Of Safety And Tolerability Of Adjuvant Chemotherapy With Continuous Infusion Paclitaxel And Dose Intense Cyclophosphamide And Hematopoietic Growth Factor Support Followed By Doxorubicin For Stage II-IIIA Breast Cancer Involving Greater Than or Equal to 10 Lymph Nodes

Case Comprehensive Cancer Center ClinicalTrials.gov

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5 other identifiers

CWRU1100P30CA04370305-00-23NCI-G00-1877NCI-2010-01068

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2003

StartedJul 2000

CompletionSep 2012

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with filgrastim and radiation therapy works in treating patients with stage II or stage IIIA breast cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline

Completed

Started Jul 2000

Longer than P75 for phase_2 breast-cancer

Geographic Reach

1 country

3 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12.2 years study duration

Study Start

First participant enrolled

July 1, 2000

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed

2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed

6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed

Last Updated

October 2, 2012

Status Verified

September 1, 2012

Enrollment Period

5.9 years

First QC Date

January 6, 2001

Last Update Submit

September 28, 2012

Conditions

Breast Cancer

Keywords

stage II breast cancerstage IIIA breast cancermale breast cancer

Outcome Measures

Primary Outcomes (2)

To determine the safety of administering continuous infusion paclitaxel with dose intense cyclophosphamide
Paclitaxel 160 mg/m2 given over 72 hours by continuous infusion days 1-3 given concurrently with cyclophosphamide 700 mg/m2 daily for 3 day every 3 weeks cycles 1-3. Patients will be observed in the outpatient treatment area during the first 2 hours of the paclitaxel infusion for allergic reactions. Epinephrine, hydrocortisone, and IV antihistamine will be available.
9 weeks
To determine the incidence of febrile neutropenia with the first cycle of therapy.
A specific objective of this trial is to estimate the incidence of febrile neutropenia. The observed incidence of febrile neutropenia with the first cycle of cyclophosphamide and paclitaxel, as well as the observed number of days of grade ¾ neutropenia during the first treatment cycle, will be reported along with 95% confidence intervals.
3 weeks

Secondary Outcomes (5)

To determine days of neutrophil counts below 500/uL on this regimen during the first treatment cycle.
after 1st cycle (3 weeks)
To evaluate dose delays and dose reductions of this regimen.
at 7 cycles (21 weeks)
To determine disease-free and overall survival of this regimen.
5 yrs after treatment
Quality of life as assessed by Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire
6 months after treatment
Correlation of Her2/neu overexpression with disease-free and overall survival
5 yrs after treatment

Study Arms (1)

Arm A: Combination Chemotherapy

EXPERIMENTAL

Paclitaxel IV continuously over 72 hours on days 1-3 and cyclophosphamide IV on days 1-3. Filgrastim subcutaneously (SC) beginning on day 5 and continuing until blood counts recover or pegfilgrastim SC on day 5. Treatment repeats every 21 days for 3 courses. Then doxorubicin hydrochloride IV on day 1 and filgrastim SC beginning on day 2 and continuing until blood counts recover or pegfilgrastim SC on day 2. Treatment repeats every 21 days for 4 courses. Patients with hormone-receptor positive tumors receive oral tamoxifen citrate or oral anastrozole daily for 5 years following chemotherapy. Beginning 3-6 weeks after completion of chemotherapy, patients undergo radiation therapy 5 days a week for 6-7 weeks.

Biological: filgrastimDrug: cyclophosphamideDrug: doxorubicin hydrochlorideDrug: paclitaxelDrug: tamoxifen citrateProcedure: adjuvant therapyRadiation: radiation therapy

Interventions

filgrastimBIOLOGICAL

Neupogen (G-CSF) given at a dose of 10 ugm/kg subcutaneously starting on day 5 and continuing until ANC \> 10,000/uL x1 day after the nadir cycles 1-3.

Also known as: G-CSF, Neupogen®, recominant-methionyl human granulocyte-colony stimulating factor, granulocyte colony stimulating factor, r-methHuG-CSF