Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of vinorelbine plus trastuzumab in treating patients who have refractory or metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: trastuzumab Drug: vinorelbine ditartrate |
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: | Phase I Clinical Trial Of Vinorelbine (Navelbine) And Trastuzumab (Herceptin) In Patients With Carcinoma Of The Breast Or Non-Small Cell Lung Cancer And HER-2/NEU Overexpression |
| Enrollment: | 13 |
| Study Start Date: | November 1999 |
| Primary Completion Date: | September 2002 (Final data collection date for primary outcome measure) |
-
Biological: trastuzumab
Trastuzumab (INN; trade name Herceptin) is a monoclonal antibody that interferes with the HER2/neu receptor. Its main use is to treat certain breast cancers.
The HER receptors are proteins that are embedded in the cell membrane and communicate molecular signals from outside the cell to inside the cell, and turn genes on and off. The HER proteins regulate cell growth, survival, adhesion, migration, and differentiation—functions that are amplified or weakened in cancer cells. In some cancers, notably some breast cancers, HER2 is over-expressed, and causes breast cells to reproduce uncontrollably.
OBJECTIVES:
- Determine the maximum tolerated dose of vinorelbine in combination with trastuzumab (Herceptin) in patients with HER-2/neu overexpressing unresectable or metastatic non-small cell lung cancer (closed to accrual as of 4/16/01) or refractory locally advanced or metastatic breast cancer.
- Determine the pharmacokinetic and pharmacodynamic profiles of this regimen in this patient population.
- Determine the objective response rate of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of vinorelbine.
Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8, and trastuzumab (Herceptin) IV over 30-90 minutes on days 8 and 15 of course 1 and days 1, 8, and 15 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 30-35 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed unresectable or metastatic non-small cell lung cancer
- Stage IIIB or IV (closed to accrual as of 4/16/01) OR
- Histologically confirmed locally advanced breast cancer that has progressed after first-line chemotherapy or metastatic breast cancer
- HER-2/neu overexpression (1+ to 3+)
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Menopausal status:
- Not specified
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- ALT no greater than 3 times ULN
Renal:
- Creatinine no greater than 2 times ULN
Cardiovascular:
- No prior or concurrent unstable angina
- No prior symptomatic congestive heart failure
- No myocardial infarction within the past 6 months
- LVEF at least 45% by echocardiogram or MUGA if received prior anthracycline or anthrapyrazole therapy
Other:
- No prior hypersensitivity to trastuzumab, Chinese hamster ovary cell proteins, or any component of these products
- No other medical illness that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior trastuzumab (Herceptin)
Chemotherapy:
- See Disease Characteristics
- No prior vinorelbine
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Contacts and Locations| United States, New Hampshire | |
| Norris Cotton Cancer Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| Study Chair: | Peter A. Kaufman, MD | Norris Cotton Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dartmouth-Hitchcock Medical Center |
| ClinicalTrials.gov Identifier: | NCT00014430 History of Changes |
| Other Study ID Numbers: | CDR0000068543, P30CA023108, DMS-9904, NCI-G01-1932 |
| Study First Received: | April 10, 2001 |
| Last Updated: | March 12, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Dartmouth-Hitchcock Medical Center:
|
stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage IIIB breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Vinorelbine Vinblastine Trastuzumab |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013