Filgrastim Plus Chemotherapy Compared With Filgrastim Alone In Treating Women Undergoing Peripheral Stem Cell Transplantation For Breast Cancer

NCT00002836 | Completed Phase 3

• 5 other identifiers: DM95-047P30CA016672MDA-DM-95047NCI-G96-1014CDR0000065048
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which treatment regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus filgrastim with filgrastim alone in treating women undergoing peripheral stem cell transplantation for stage II, stage III, or metastatic breast cancer.

Conditions

Breast Cancer

Keywords

recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

• Compare Effectiveness of Chemotherapy + Filgrastim to Filgrastim Alone

  90 Days Post Transplant

Study Arms (2)

Filgrastim + Chemotherapy

EXPERIMENTAL

Biological: Filgrastim (G-CSF); Drug: Carmustine; Drug: Cisplatin; Drug: Cyclophosphamide (CTX); Drug: Etoposide; Drug: Thiotepa; Procedure: Peripheral Blood Stem Cell Transplantation

Filgrastim

EXPERIMENTAL

Biological: Filgrastim (G-CSF); Drug: Carmustine; Drug: Cyclophosphamide (CTX); Drug: Thiotepa; Procedure: Peripheral Blood Stem Cell Transplantation

Interventions

Filgrastim (G-CSF) BIOLOGICAL

For group one (Filgrastim + Chemotherapy), given under the skin (SC) on day 4 every 12 hours until completion of apheresis; for group two (Filgrastim alone), beginning on day of reinfusion twice a day (bid) until white blood count (WBC) reaches a safe level.

Also known as: Neupogen, G-CSF

Filgrastim; Filgrastim + Chemotherapy

Carmustine DRUG

Upon recovery of hematopoiesis patients then receive high by vein (IV) doses of CBT chemotherapy with CTX, carmustine, and thiotepa for 3 days

Also known as: BCNU, BiCNU

Filgrastim; Filgrastim + Chemotherapy

Cisplatin DRUG

As part of CVP chemotherapy treatment by vein (IV) on days 1-3.

Also known as: Platinol-AQ, Platinol, CDDP

Filgrastim + Chemotherapy

Cyclophosphamide (CTX) DRUG

In group one (Filgrastim + Chemotherapy) as part of CVP chemotherapy treatment by vein (IV) on days 1-3; and group two (Filgrastim alone), upon recovery of hematopoiesis receive high IV doses of CBT chemotherapy with CTX, carmustine, and thiotepa for 3 days.

Also known as: Cytoxan, Neosar

Filgrastim; Filgrastim + Chemotherapy

Etoposide DRUG

CVP chemotherapy treatment IV on days 1-3, with cyclophosphamide (CTX), etoposide, and cisplatin.

Also known as: VePesid

Filgrastim + Chemotherapy

Thiotepa DRUG

Upon recovery of hematopoiesis receive high IV doses of CBT chemotherapy with CTX, carmustine, and thiotepa for 3 days.

Filgrastim; Filgrastim + Chemotherapy

Peripheral Blood Stem Cell Transplantation PROCEDURE

Infusion of stem cells on Day 0.

Also known as: PBSCT, Stem Cell Transplant

Filgrastim; Filgrastim + Chemotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Female patients with Stage II, III or IV breast carcinoma in remission, and not eligible for protocols of higher priority (DM89-102) Stage II breast cancer must have spread to at least 10 axillary nodes; patients with fewer than 10 nodes must have extranodal extensions Patients with greater than 75% positive nodes for tumor are eligible No bone marrow involvement with tumor by standard histopathological exam of bilateral iliac marrow biopsies 2 weeks prior to study Prior normalization of markers needed in patients with elevated tumor markers (e.g., CEA) Metastatic disease patients must have documentation verifying at least 50% reduction of all sites of disease, except bone Stable bone metastases measured via bone scan are eligible Responsive disease but with large tumor burden should enter high risk BMT protocols (93-090) PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 No hematopoietic growth factor treatments Hepatic: Bilirubin, SGOT, and SGPT less than 2 times normal Renal: Estimated creatinine clearance greater than 60 mL/min Cardiovascular: Normal ejection fraction Pulmonary: DLCO greater than 50% of predicted Other: Not HIV positive Not pregnant 2 weeks prior to study No comorbid condition placing patient at high risk for complications No prior active infections No history of untreated central nervous system (CNS) disease No allergic response to eggs or murine protein PRIOR CONCURRENT THERAPY: No concurrent involvement in any other clinical trial that effects engraftment Biologic therapy: No growth factors within 1 week Chemotherapy: No more than 2 chemotherapy regimens allowed after relapse for metastatic disease Chemotherapy responsive disease prior to study Stage II/III disease receiving neoadjuvant chemotherapy allowed with at least 4 positive nodes at mastectomy No partial response to chemotherapy less than 50% of any site except bone No prior chemotherapy treatment with carmustine Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Mastectomy allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Filgrastim; Granulocyte Colony-Stimulating Factor; Carmustine; Cisplatin; Cyclophosphamide; Etoposide; Thiotepa; Peripheral Blood Stem Cell Transplantation; Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hematopoietic Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• James Gajewski, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: November 24, 2003
• Study Start: September 26, 1995
• Primary Completion: March 9, 2006
• Study Completion: March 9, 2006
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

US (1)