Suspended

Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer

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What is being tested

celecoxib

+ vinorelbine ditartrate
Drug
Who is being recruted

Breast Cancer

From 18 to 120 Years
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: November 2003

Summary

Principal SponsorCase Comprehensive Cancer Center
Last updated: July 27, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2003Actual date on which the first participant was enrolled.

RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vinorelbine with celecoxib may kill more tumor cells. PURPOSE: Phase I trial to determine the effectiveness of combining vinorelbine with celecoxib in treating women who have relapsed or metastatic breast cancer. OBJECTIVES: * Determine the maximum tolerated dose of vinorelbine and celecoxib in women with relapsed or metastatic breast cancer. * Determine the safety profile of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral celecoxib twice daily on days 1-21 and oral vinorelbine on days 7, 14, and 21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of celecoxib and vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study.

Official TitleA Phase I Study of Weekly Administration of Oral Navelbine in Combination With the COX-2 Inhibitor Celebrex in Relapsed and/or Metastatic Breast Cancer 
Principal SponsorCase Comprehensive Cancer Center
Last updated: July 27, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
6 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Cancer
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Recurrent or metastatic (stage IV) disease * Incurable disease * Measurable or evaluable disease * Stable brain metastases allowed * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL Hepatic * Bilirubin normal * AST/ALT ≤ 2.5 times upper limit of normal Renal * Creatinine normal OR * Creatinine clearance ≥ 60 mL/min * No clinically significant proteinuria * No impaired renal function Cardiovascular * No symptomatic congestive heart failure * No unstable angina * No cardiac arrhythmia * No inadequately controlled hypertension Gastrointestinal * No disorder that would alter gastrointestinal motility or absorption * No dysphagia * Able to swallow tablets or capsules Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No hypersensitivity to celecoxib * No prior urticaria, asthma, or other allergic-type reaction after taking aspirin or other nonsteroidal anti-inflammatory drugs * No allergy to sulfa * No other concurrent uncontrolled illness * No psychiatric illness or social situation that would preclude study compliance * No ongoing or active infection PRIOR CONCURRENT THERAPY: Biologic therapy * At least 3 weeks since prior trastuzumab (Herceptin®) and recovered * No concurrent hematopoietic growth factors Chemotherapy * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * Prior adjuvant or neoadjuvant chemotherapy allowed * Prior chemotherapy for recurrent or metastatic disease allowed * No prior vinorelbine Endocrine therapy * At least 2 weeks since prior hormonal therapy * Prior adjuvant or neoadjuvant hormonal therapy allowed * Prior hormonal therapy for recurrent or metastatic disease allowed Radiotherapy * At least 4 weeks since prior radiotherapy for metastatic disease * Prior adjuvant radiotherapy allowed Surgery * Not specified Other * At least 3 weeks since prior investigational anticancer agents and recovered * At least 1 week since prior cyclooxygenase-2 (COX-2) inhibitors, except celecoxib * No concurrent administration of any of the following drugs: * Lithium * Fluconazole * Aluminum antacids * Magnesium antacids * Concurrent H_2 blocking agents or proton pump inhibitors allowed for the treatment of dyspepsia or gastroesophageal reflux disease * Concurrent bisphosphonates allowed


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, United StatesSee the location

SuspendedOne Study Center