A Multicentre Phase I-II Study to Investigate the Combination of Bendamustine With Weekly Paclitaxel as First or Second Line Therapy in Patients With Metastatic Breast Cancer

NCT00661739 | Completed Phase 1 DMC

• 1 other identifier: GBG 38
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to establish a feasible combination of bendamustine and paclitaxel in a weekly schedule. The two agents have different toxicity profiles and are well tolerated when given in a weekly fashion. The combination might be of special interest for elderly patients with hormone insensitive breast cancer

Conditions

Metastatic Breast Cancer

Keywords

palliative; Breast cancer; metastatic; Bendamustine; phase I

Outcome Measures

Primary Outcomes (1)

• The phase I part of the trial should evaluate the maximal tolerated dose (MTD) for the combination of bendamustine with paclitaxel.

  end of cycle 2 of the 6th patient of the assumed highest dose level

Secondary Outcomes (1)

• To determine the objective response rate (phase II part)

  EOT last patient (phase II part)

Study Arms (1)

Singular Arm

EXPERIMENTAL

Bendamustine treatment

Drug: Bendamustine

Interventions

Bendamustine DRUG

Dose-level Bendamustine(mg/m²): I:50; II:60; III:60; IV:70; V:70 Dose-level Paclitaxel (mg/m²): I:60; II:60; III:80; IV:80; V:90 Treatment will be given on day 1,8,15 and repeated on day 29. When the recommended dose has been determined a total of 48 pts will be treated at this dose level.

Also known as: Ribomustine

Singular Arm

Eligibility Criteria

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

You may qualify if:

• Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures;
• Pathological confirmed primary carcinoma of the breast.
• Locally advanced or metastatic disease
• Up to one previous palliative chemotherapy that did not contain docetaxel or paclitaxel. Previous adjuvant treatment with taxanes is allowed when the last application of the taxane was given at least 1 year before entering the trial.
• Patients must have either measurable or non-measurable lesions according to the WHO criteria
• At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiated field or there must be pathological proof of progressive disease.
• Complete radiological and clinical tumor assessment within 4 weeks prior to registration performed as clinically indicated
• Karnofsky-Index ≥ 60 %
• Age ≥ 18 years
• Absolute neutrophil count ≥ 1,500 cells/µl, platelets ≥ 100,000/µl, and hemoglobin ≥ 9 g/dl
• Bilirubin within normal limits; evaluation of transaminases and alkaline phosphatase ≤ 5x upper normal limit
• Serum creatinine ≤ 2.0 mg/dl
• Normal left ventricular ejection fraction (LVEF) by echocardiogramme
• Patients of childbearing potential, pregnancy test must be negative
• If fertile effective contraception must be used throughout the study

You may not qualify if:

• Known or suspected hypersensitivity reaction to the investigational compounds or incorporated substances;
• Concurrent immunotherapy or hormonal treatment for cancer (Bisphosphonates may be continued)
• Symptomatic parenchymal brain metastases not responding to treatment
• Life expectancy less than 3 months
• Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study
• Concurrent treatment with other experimental drugs or any other anti-cancer therapy within the last 28 days;
• History of congestive heart failure or other significant uncontrolled cardiac disease
• Pregnant or nursing women

Sponsors & Collaborators

• GBG Forschungs GmbH: lead

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 18, 2008
• Study Start: July 1, 2005
• Primary Completion: September 1, 2010
• Study Completion: May 1, 2011
• Last Updated: September 2, 2011

Record last verified: 2010-09