R101933 Combined With Chemotherapy in Treating Patients With Metastatic Breast Cancer That Has Not Responded to Previous Chemotherapy

NCT00028873 | Completed Phase 2

• 4 other identifiers: EORTC-10003-16004EORTC-16004ECSG-EORTC-16004IDBBC-10003
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining R101933 with paclitaxel or docetaxel may reduce resistance to the drug and allow the tumor cells to be killed. PURPOSE: Phase II trial to study the effectiveness of combining R101933 with either paclitaxel or docetaxel in treating patients who have metastatic breast cancer that has not responded to previous chemotherapy.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

docetaxel DRUG

laniquidar DRUG

paclitaxel DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic breast cancer * Received at least 2 prior courses of paclitaxel-based chemotherapy at doses between 175-200 mg/m\^2 (given over 3 hours every 3 weeks) or docetaxel-based chemotherapy at doses between 75-100 mg/m\^2 (given over 1 hour every 3 weeks) as most recent anticancer therapy * Evidence of disease resistance * Progressive disease as best response OR * Transient response or disease stabilization followed by progression during taxane-based treatment * Disease progression on a combination of a taxane and another cytotoxic agent allowed * Unidimensionally measurable disease * At least 1 target lesion that clearly progressed or developed during prior taxane therapy * Lesions stable or responsive to prior taxane therapy are not considered target lesions * Lesions that have been irradiated within the past 3 months are not considered target lesions unless they have clearly progressed or appeared since radiotherapy * No bone metastases as only site of measurable disease * No rapidly progressive visceral metastases * No symptomatic CNS metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Not specified Menopausal status: * Not specified Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present) Renal: * Creatinine no greater than 1.5 times ULN * Calcium normal Cardiovascular: * LVEF normal by echocardiogram (ECG) or MUGA scan * QTc less than 450 sec on baseline ECG * No prior clinically significant arrhythmias requiring treatment * No cardiac infarction * No atrial ventricular enlargement or hypertrophy Other: * No prior toxicity to paclitaxel that would preclude study dose and schedule * Sodium, potassium, chloride, and bicarbonate normal * No pre-existing neuropathy greater than grade 2 * No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix, contralateral breast cancer, or nonmelanoma skin cancer or cancer that has been in remission for more than 5 years * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent anticancer biologic agents Chemotherapy: * See Disease Characteristics * No more than 8 weeks since last course of prior taxane-based chemotherapy * No more than 2 prior chemotherapy regimens for metastatic breast cancer * No other concurrent anticancer chemotherapy Endocrine therapy: * No concurrent anticancer hormonal therapy Radiotherapy: * See Disease Characteristics * No concurrent radiotherapy Surgery: * Not specified Other: * No prior multi-drug resistance inhibitor * No new anticancer therapy initiation since last course of prior taxane-based chemotherapy * No concurrent angiotensin converting enzyme inhibitor and/or drugs that may prolong the QTc interval * No other concurrent anticancer therapy * Concurrent bisphosphonates for treatment and prevention of bony metastases allowed provided drugs were initiated prior to study (treatment of hypercalcemia due to malignancy allowed regardless of time of initiation)

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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (2)

Institut Jules Bordet

Brussels, B-1000, Belgium

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; laniquidar; Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Bernardo L. Rapoport, MD, MMed(IntMed)

  Medical Oncology Centre of Rosebank

  STUDY CHAIR

• Pierre Fumoleau, MD, PhD

  Centre Georges Francois Leclerc

  STUDY CHAIR

• Martine J. Piccart-Gebhart, MD, PhD

  Jules Bordet Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2002
• First Posted: January 27, 2003
• Study Start: September 1, 2001
• Primary Completion: June 1, 2002
• Last Updated: July 18, 2012

Record last verified: 2012-07

Locations

BE (1); FR (1)