Evaluation of BNP7787 for the Prevention of Neurotoxicity in Metastatic Breast Cancer Patients Receiving Weekly Paclitaxel

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by BioNumerik Pharmaceuticals, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
BioNumerik Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00039780
First received: June 10, 2002
Last updated: April 13, 2012
Last verified: April 2009
  Purpose

The purpose of this study is to determine whether BNP7787 is effective in preventing or reducing neurotoxicity (nerve damage) caused by paclitaxel (Taxol®).


Condition Intervention Phase
Breast Neoplasms
Breast Diseases
Metastases, Neoplasm
Drug: BNP7787
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BNP7787 vs. Placebo for Prevention of Paclitaxel Neurotoxicity: A Double-Blind Multicenter Randomized Phase 3 Trial in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by BioNumerik Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 1)Incidence of PNQ Grade D or Grade E neurosensory symptoms (Item 1 of the PNQ) with duration of at least 4 weks; 2) Objective tumor response rate [ Time Frame: baseline to disease progression or discontinuation from study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of Dose Modifications, Treatment Delays and Treatment Discontinuations due to Neurotoxicity [ Time Frame: baseline to end of treatment ] [ Designated as safety issue: Yes ]
  • Time-to-onset of clinically important neurotoxicity [ Time Frame: randomization to date of first occurrence of clinically important neurotoxicity ] [ Designated as safety issue: Yes ]
  • Incidence of Neurosensory and Neuromotor Functional Impairment [ Time Frame: baseline through end of treatment ] [ Designated as safety issue: Yes ]
  • Progression Free Survival [ Time Frame: Randomization to disease progression or death due to any cause ] [ Designated as safety issue: No ]

Enrollment: 764
Study Start Date: September 2001
Estimated Study Completion Date: September 2014
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Tavocept (BNP7787)
Drug: BNP7787
The treatment regimen administered in this study is a single IV doxe of paclitaxel (80 mg/m2) +/- Herceptin given over 1 hour and either BNP7787 (18.4 g/m2) or placebo given over 45 minutes each week. One treatment cycle = 8 weeks.
Other Name: BNP7787 also known as Tavocept
Placebo Comparator: 2
0.9% Sodium Chloride Soln.
Drug: Placebo
The treatment regimen administered in this study is a single IV doxe of paclitaxel (80 mg/m2) +/- Herceptin given over 1 hour and either BNP7787 (18.4 g/m2) or placebo given over 45 minutes each week. One treatment cycle = 8 weeks.

Detailed Description:

Chemotherapy induced toxicities are common and serious problems for many patients who receive treatment for cancer. Chemotherapy induced toxicities can adversely impact the quality of life and the ability of patients to continue treatment for their cancer. One such toxicity associated with the use of paclitaxel (Taxol®) is peripheral neurotoxicity.

Paclitaxel is an active drug in the treatment of metastatic breast cancer as first-line treatment and in patients with recurrent or refractory disease, including patients who have failed to respond to previous anthracycline therapy. Recent studies with paclitaxel using a weekly schedule of administration have demonstrated higher tumor response rates and disease free survival accompanied by a shift in the frequency of certain toxicities, increased dose intensity and a potential means to improve the treatment schedule of paclitaxel for improved patient benefit.

Paclitaxel induced neurotoxicity remains an important problem that limits the ability to improve the schedule of administration of this drug. To date, there is no effective or FDA approved therapy to prevent the development of or reduce the frequency or severity of paclitaxel-induced neurotoxicity.

BNP7787 is an investigational new drug that is undergoing development for chemoprotection of platinum and taxane associated common clinical toxicities, particularly the prevention of chemotherapy-induced neurotoxicity.

In this Phase 3 clinical trial the safety and effectiveness of BNP7787 in preventing or mitigating the frequency, severity, worsening of grade, time to onset, duration and discontinuation of therapy due to paclitaxel-induced neurotoxicity will be assessed in patients with metastatic breast cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

Histologically or cytologically documented metastatic breast cancer

Measurable disease

Performance Status; ECOG 0-2

More than 2 weeks since prior radiation therapy

14 days or more since prior therapy and recovered from all side effects

For patients who progress while receiving hormonal therapy alone, the patient may be enrolled on study as soon as they have recovered from all side effects of the hormonal therapy

Clinical laboratory values must meet the following:

  • Granulocytes greater than or equal to 1,500/mm(3)
  • Platelets greater than or equal to 100,000/mm(3)
  • Hemoglobin greater than or equal to 9 g/dL
  • SGOT less than 2.0 x ULN
  • Bilirubin less than or equal to 1.5 mg/dL
  • Creatinine less than or equal to 1.6 mg/dL
  • Calcium less than the ULN

EXCLUSION CRITERIA

Current CNS metastases or history of CNS metastases

History of diabetes (Type I or Type II)

Previous or concurrent malignancy except:

  • inactive non-melanoma skin cancer
  • in situ carcinoma of the cervix
  • or other cancer if the patient has been disease-free for more than 5 years

Pregnant or lactating women

History of recent myocardial infarction, stroke, or uncontrolled CHF, epilepsy, or hypertension

Patients currently receiving Neurontin® (gabapentin), glutamine supplements, Elavil® (amitriptyline), Dilantin®, Tegretol®, tricyclic antidepressants or other similar medications during the study period

Alternative medications including megadose vitamins, herbal preparations, tonics, extracts, etc. are not allowed during the study period.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: BioNumerik Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00039780     History of Changes
Other Study ID Numbers: DMS30203R
Study First Received: June 10, 2002
Last Updated: April 13, 2012
Health Authority: United States: Food and Drug Administration
Unitd States: WIRB
Russia: Ethics Committee
Russia: Pharmacological Committee, Ministry of Health

Keywords provided by BioNumerik Pharmaceuticals, Inc.:
Neurotoxicity
Breast
Cancer
Metastatic
Paclitaxel
Peripheral
Taxol
Neuropathy
Paresthesias
Weekly
BNP7787
7787
Tavocept
Prevention

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Breast Diseases
Breast Neoplasms
Neoplasm Metastasis
Neoplasms
Chemically-Induced Disorders
Neoplasms by Site
Neoplastic Processes
Nervous System Diseases
Pathologic Processes
Poisoning
Skin Diseases
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 29, 2014