Trial of Ixabepilone in Patients With HER-2 Negative Metastatic Breast Cancer (HIT)

NCT00790894 | Terminated Phase 2

• 1 other identifier: HE 11A08
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 13

Brief Summary

This is a Phase II Randomized, Open Label, Non-comparative Trial (Parallel Assignment and Efficacy Study) for patients with HER-2 Negative Metastatic Breast Cancer Previously Treated With chemotherapy in the Neo-Adjuvant or Adjuvant Setting.Patients will be randomized to receive Ixabepilone either every three weeks, or weekly for three weeks followed by one week off. Patients will be treated until consent withdrawal, intolerable toxicity or documented disease progression

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of the study is the best Overall Response (OR).

  At 6, 12 and 24 weeks

Secondary Outcomes (3)

• Efficacy endpoints: time to response, PFS, TTF, duration of response

  Duration of the study

• OS Toxicity endpoints: incidence of hematological and non-hematological toxicities

  Duration of the study

• Translational endpoints

  Duration of the study

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: ixabepilone

2

EXPERIMENTAL

Drug: ixabepilone

Interventions

ixabepilone DRUG

Arm A: ixabepilone will be given at a dose of 40 mg/m2 as a 3-hour intravenous infusion on Day 1 in a 21 days cycle.

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Female patients aged 18 to 75 years inclusive
• Prior chemotherapy in the adjuvant or neo-adjuvant setting
• Diagnosis of HER-2 negative (HER-2 \<2+ by immunohistochemistry and/or FISH negative) metastatic breast adenocarcinoma confirmed by the pathology department of the enrolling institution
• Eastern Cooperative Oncology Group performance status of 0 or 1
• Life expectancy of at least 12 weeks
• Measurable disease by the Response Criteria in Solid Tumors (RECIST) method
• Laboratory values within the specified ranges within 1 week of study enrolment:
• Absolute neutrophil count of ≥ 1.5 x 109/L
• Thrombocyte count of ≥ 100 x 109/L
• Subjects must not have received cytotoxic chemotherapy for locally recurrent/metastatic disease
• Prior hormonal therapy for locally recurrent or metastatic disease allowed
• AST and ALT ≤ 2.5 x ULN
• Bilirubin ≤ 1.5 x ULN
• Recovery from prior palliative radiotherapy for bone metastases

You may not qualify if:

• Because of concerns that ixabepilone metabolism may be inhibited by potent cytochrome P450 3A4 inhibitors, patients must not receive the following medications, up to 72 hours prior to initiation of study therapy and until they come off treatment with ixabepilone: amprenavir, delavirdine, voriconazole, erythromycin, cyclosporine, troleandomycin, terfenadine, ketoconazole, nelfinavir, and ritonavir
• Patients with CTC grade 2 or greater neuropathy at baseline
• Patients with any history or evidence of brain an/or leptomenigneal metastasis
• Patients with clinically significant cardiac disease (e.g. unstable angina, congestive heart failure, myocardial infarction) within 6 months from study entry
• Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocol
• Any concurrent active malignancy other than non-melanoma skin cancer or in situ carcinoma of the cervix (subjects with a history of previous malignancies but without evidence of disease for 5 years will be allowed to enter the trial)
• Prior severe HSR to agents containing Cremophor EL
• Women of childbearing potential (WOCBP) who are unwilling or unable to use an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks from the last dose of ixabepilone, in such a manner that the risk of pregnancy is minimized WOCBP include: any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea ≥ 12 consecutive months; women on hormone replacement therapy with documented FSH level \> 35mIU/mL. Even women who are practising abstinence or whom their partner is sterile (e.g. vasectomy) should be considered of childbearing potential.
• Women who are pregnant or breastfeeding
• Women with a positive pregnancy test on enrolment or prior to study therapy
• No other concomitant chemotherapy, endocrine therapy, immunotherapy, radiation therapy (except for palliative radiotherapy for bone metastases) or investigational treatments are allowed during subject's participation in the study

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Study Sites (13)

Hippokration General Hospital, Oncology Department

Athens, 11527, Greece

Location

University Hospital Attikon, Second Department of Internal Medicine, Oncology Section

Athens, 12462, Greece

Location

Agii Anargiri Cancer Hospital, Third Department of Medical Oncology

Athens, 13122, Greece

Location

Hygeia Hospital, First Deparment of Medical Oncology

Athens, 15123, Greece

Location

Hygeia Hospital, Second Department of Medical Oncology

Athens, 15123, Greece

Location

Alexandra Hospital, Department of Clinical Therapeutics

Athens, Greece

Location

University General Hospital of Ioannina, Medical Oncology Department

Ioannina, 45500, Greece

Location

University Hospital of Larisa, Department of Medical Oncology

Larissa, 41110, Greece

Location

University Hospital of Patras, Department of Medicine, Division of Oncology

Pátrai, 265 00, Greece

Location

Metropolitan Hospital, First Department of Medical Oncology

Piraeus, 18547, Greece

Location

Metropolitan Hospital, Second Dept of Medical Oncology

Piraeus, 18547, Greece

Location

"Theageneio" Cancer Hospital, Third Department of Medical Oncology

Thessaloniki, 54007, Greece

Location

"Papageorgiou" General Hospital, Department of Medical Oncology

Thessaloniki, 56429, Greece

Location

Related Publications (1)

• Fountzilas G, Kotoula V, Pectasides D, Kouvatseas G, Timotheadou E, Bobos M, Mavropoulou X, Papadimitriou C, Vrettou E, Raptou G, Koutras A, Razis E, Bafaloukos D, Samantas E, Pentheroudakis G, Skarlos DV. Ixabepilone administered weekly or every three weeks in HER2-negative metastatic breast cancer patients; a randomized non-comparative phase II trial. PLoS One. 2013 Jul 23;8(7):e69256. doi: 10.1371/journal.pone.0069256. Print 2013.

  PMID: 23935969 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

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

Study Officials

• George Fountzilas

  Papageorgiou General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 14, 2008
• Study Start: November 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 18, 2011

Record last verified: 2011-05

Locations

GR (13)