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 (RiTa)
This study has been completed.
Sponsor:
German Breast Group
Information provided by (Responsible Party):
German Breast Group
ClinicalTrials.gov Identifier:
NCT00661739
First received: April 15, 2008
Last updated: August 31, 2011
Last verified: September 2010
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer |
Drug: Bendamustine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by German Breast Group:
Primary Outcome Measures:
- The phase I part of the trial should evaluate the maximal tolerated dose (MTD) for the combination of bendamustine with paclitaxel. [ Time Frame: end of cycle 2 of the 6th patient of the assumed highest dose level ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine the objective response rate (phase II part) [ Time Frame: EOT last patient (phase II part) ] [ Designated as safety issue: No ]
| Enrollment: | 38 |
| Study Start Date: | July 2005 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Singular Arm
Bendamustine treatment
|
Drug: Bendamustine
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.
Other Name: Ribomustine
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | German Breast Group |
| ClinicalTrials.gov Identifier: | NCT00661739 History of Changes |
| Other Study ID Numbers: | GBG 38 |
| Study First Received: | April 15, 2008 |
| Last Updated: | August 31, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by German Breast Group:
|
palliative Breast cancer metastatic Bendamustine phase I |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Bendamustine Nitrogen Mustard Compounds Paclitaxel Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013