Navelbine

Uterine Cervical Neoplasms, Monotherapy, Metastatic Breast Cancer + 4 more

Treatment

4 FDA approvals

20 Active Studies for Navelbine

What is Navelbine

Vinorelbine

The Generic name of this drug

Treatment Summary

Vinorelbine is a chemotherapy drug used to treat breast cancer and non-small cell lung cancer (NSCLC). It was approved by the FDA in the 1990s specifically for NSCLC. Vinorelbine belongs to a group of drugs known as vinca alkaloids, which have been found to improve survival rates in patients with advanced NSCLC. However, treatment with vinorelbine can cause serious side effects. A study was done that showed that genetic mutations can affect how quickly the body clears vinorelbine, with some patients clearing the drug up to 4.3 times faster than others

Vinorelbine

is the brand name

Navelbine Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Vinorelbine

Vinorelbine

2003

22

Approved as Treatment by the FDA

Vinorelbine, otherwise called Vinorelbine, is approved by the FDA for 4 uses which include Metastatic Non-Small Cell Lung Cancer and Carcinoma, Non-Small-Cell Lung .

Metastatic Non-Small Cell Lung Cancer

Used to treat Metastatic Non-Small Cell Lung Cancer in combination with Cisplatin

Carcinoma, Non-Small-Cell Lung

Used to treat Locally Advanced Non-Small Cell Lung Cancer in combination with Cisplatin

Previously Untreated

Used to treat Previously Untreated in combination with Cisplatin

Malignant Neoplasms

Used to treat Metastatic Non-Small Cell Lung Cancer in combination with Cisplatin

Effectiveness

How Navelbine Affects Patients

Vinorelbine is a medication used to fight tumors. It belongs to a group of drugs called vinca-alkaloids, which stop cancer cells from dividing by preventing them from forming the structures needed for cell division.

How Navelbine works in the body

Vinorelbine tartrate is a special type of vinca alkaloid that works to fight cancer. It does this by inhibiting the process of cell division, by attaching to the microtubule proteins in the cell. This prevents cells from dividing and reproducing, resulting in cell death. Vinorelbine also works to activate certain tumor suppressor genes, like p53, and deactivate certain cancer-promoting proteins. It also affects metabolism, respiration, and other essential cell functions. All of these effects together lead to the death of cancerous cells.

When to interrupt dosage

The dosage of Navelbine is contingent upon the diagnosed issue, including Monotherapy, Soft Tissue Sarcoma and Malignant Neoplasms. The quantity of dosage is further dependent upon the administration approach (e.g. Solution - Intravenous or Solution) elucidated in the accompanying table.

Condition

Dosage

Administration

Uterine Cervical Neoplasms

, 10.0 mg/mL, 50.0 mg/mL

Injection, solution - Intravenous, , Intravenous, Injection, solution, Injection, solution, concentrate, Injection, solution, concentrate - Intravenous, Injection - Intravenous, Injection, Solution, Solution - Intravenous

Monotherapy

, 10.0 mg/mL, 50.0 mg/mL

Injection, solution - Intravenous, , Intravenous, Injection, solution, Injection, solution, concentrate, Injection, solution, concentrate - Intravenous, Injection - Intravenous, Injection, Solution, Solution - Intravenous

Carcinoma, Non-Small-Cell Lung

, 10.0 mg/mL, 50.0 mg/mL

Injection, solution - Intravenous, , Intravenous, Injection, solution, Injection, solution, concentrate, Injection, solution, concentrate - Intravenous, Injection - Intravenous, Injection, Solution, Solution - Intravenous

Malignant Neoplasms

, 10.0 mg/mL, 50.0 mg/mL

Injection, solution - Intravenous, , Intravenous, Injection, solution, Injection, solution, concentrate, Injection, solution, concentrate - Intravenous, Injection - Intravenous, Injection, Solution, Solution - Intravenous

Soft Tissue Sarcoma

, 10.0 mg/mL, 50.0 mg/mL

Injection, solution - Intravenous, , Intravenous, Injection, solution, Injection, solution, concentrate, Injection, solution, concentrate - Intravenous, Injection - Intravenous, Injection, Solution, Solution - Intravenous

Previously Untreated

, 10.0 mg/mL, 50.0 mg/mL

Injection, solution - Intravenous, , Intravenous, Injection, solution, Injection, solution, concentrate, Injection, solution, concentrate - Intravenous, Injection - Intravenous, Injection, Solution, Solution - Intravenous

Metastatic Breast Cancer

, 10.0 mg/mL, 50.0 mg/mL

Injection, solution - Intravenous, , Intravenous, Injection, solution, Injection, solution, concentrate, Injection, solution, concentrate - Intravenous, Injection - Intravenous, Injection, Solution, Solution - Intravenous

Warnings

There are 20 known major drug interactions with Navelbine.

Common Navelbine Drug Interactions

Drug Name

Risk Level

Description

2-Methoxyethanol

Major

The risk or severity of adverse effects can be increased when Vinorelbine is combined with 2-Methoxyethanol.

9-(N-methyl-L-isoleucine)-cyclosporin A

Major

The risk or severity of adverse effects can be increased when Vinorelbine is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.

Abetimus

Major

The risk or severity of adverse effects can be increased when Vinorelbine is combined with Abetimus.

Acteoside

Major

The risk or severity of adverse effects can be increased when Vinorelbine is combined with Acteoside.

Aldosterone

Major

The risk or severity of adverse effects can be increased when Vinorelbine is combined with Aldosterone.

Navelbine Toxicity & Overdose Risk

Vinorelbine has been linked to a variety of potential side effects, including decreased white blood cell count, infections, anemia, tingling or numbness in the extremities, hair loss, difficulty breathing, nausea, constipation, vomiting, diarrhea, fatigue, abdominal pain, chest pain, jaw pain, muscle aches, joint aches, headaches, difficulty swallowing, skin rash, bleeding in the bladder, and abnormal production of a hormone. It may also affect the chromosomes in the body. These side effects vary in severity and some may be life-threatening.

image of a doctor in a lab doing drug, clinical research

Navelbine Novel Uses: Which Conditions Have a Clinical Trial Featuring Navelbine?

155 active studies are being conducted to assess the potential of Navelbine as a Monotherapy, Previously Untreated and Soft Tissue Sarcoma Treatment.

Condition

Clinical Trials

Trial Phases

Metastatic Breast Cancer

1 Actively Recruiting

Phase 1, Phase 2

Carcinoma, Non-Small-Cell Lung

13 Actively Recruiting

Phase 3, Phase 2, Early Phase 1, Not Applicable

Monotherapy

1 Actively Recruiting

Phase 1, Phase 2

Malignant Neoplasms

3 Actively Recruiting

Phase 1, Phase 2

Uterine Cervical Neoplasms

0 Actively Recruiting

Previously Untreated

0 Actively Recruiting

Soft Tissue Sarcoma

51 Actively Recruiting

Phase 2, Not Applicable, Phase 1, Phase 4, Early Phase 1, Phase 3

Navelbine Reviews: What are patients saying about Navelbine?

5

Patient Review

10/23/2013

Navelbine for Breast Cancer that has Spread to Another Part of the Body

Navelbine was fantastic for my bone and soft tissue cancer in my neck. I had weekly treatments for six months with very minimal side effects-- just some leg fatigue at the six month mark. I stopped taking it because of the leg pain, but if my current treatment stops working, I can go back on Navelbine. Right now, my cancer is stable.

5

Patient Review

7/20/2013

Navelbine for Breast Cancer that has Spread to Another Part of the Body

Navelbine was really the first treatment that helped me. I had bone mets from breast cancer and the pain was unbearable. But after beginning this medication, I felt so much better almost immediately!

5

Patient Review

7/8/2009

Navelbine for Cancer of the Uterus

My mom has been battling lung cancer for over 10 years and we've tried a lot of different treatments. This is one of the last options, but it's working really well for her. She doesn't have many side effects and is able to live a normal life including going shopping and exercising twice a week!

5

Patient Review

1/22/2009

Navelbine for Breast Cancer that has Spread to Another Part of the Body

I've been taking this medication for almost four years, and it's been working great! The only downside is the side effects, but they're manageable.

4.7

Patient Review

6/24/2013

Navelbine for Breast Cancer that has Spread to Another Part of the Body

I'm currently on my fifth cycle of this medication, and the biggest complaint I have is the fatigue. The nausea is easily dealt with a zofran/ativan combo, but the fatigue has been tough to manage. However, it's worth it because this medication has kept my cancer from growing (it's stable).

4.7

Patient Review

6/1/2017

Navelbine for Breast Cancer that has Spread to Another Part of the Body

I've now completed five out of six cycles and the results have been great so far. The main side effects I've experienced are constipation, hair thinning, and fatigue. All things considered, it's been relatively easy to tolerate.

4.3

Patient Review

8/14/2008

Navelbine for Non-Small Cell Lung Cancer

This treatment has been working well for my mother during her cancer battle. She doesn't experience any nausea, but her blood pressure can be all over the place. Additionally, she's lost hair and is very tired.

4.3

Patient Review

6/26/2008

Navelbine for Breast Cancer that has Spread to Another Part of the Body

I had a really bad headache, stomach pain, and feeling weak. I think my blood pressure was low because I felt confused, too.

4

Patient Review

4/15/2009

Navelbine for Non-Small Cell Lung Cancer

I take this once a month with few side effects and have been in remission since I started.

3

Patient Review

3/17/2011

Navelbine for Non-Small Cell Lung Cancer

My husband has been taking this medication for two months with little to no relief from his symptoms. He was diagnosed in October 2009 and we're hoping for the best, but so far this treatment hasn't helped much.

3

Patient Review

1/14/2009

Navelbine for Breast Cancer that has Spread to Another Part of the Body

I was really struggling until I stopped taking this.

3

Patient Review

2/22/2008

Navelbine for Non-Small Cell Lung Cancer

1.7

Patient Review

3/25/2012

Navelbine for Non-Small Cell Lung Cancer

This medication caused a significant decrease in my white blood cells, and I also experienced a lot of bone pain and wheezing.

1.3

Patient Review

1/17/2010

Navelbine for Breast Cancer that has Spread to Another Part of the Body

After developing a severe chest infection, I started to experience extreme gastritis and weakness. The metastases were also extremely severe.

1

Patient Review

10/29/2009

Navelbine for Non-Small Cell Lung Cancer

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Patient Q&A Section about navelbine

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How often is Navelbine given?

"The dosage of NAVELBINE should be 30 mg/m2 given as an IV either as an injection or an infusion over 6-10 minutes. This should be done once a week in combination with cisplatin 120 mg/m2 given on days 1 and 29. This process should be repeated every 6 weeks."

Answered by AI

How effective is Navelbine?

"A phase 2 clinical trial that is studying the effectiveness of navelbine (vinorelbine) as a single-agent first-line treatment is showing a partial response rate of 24%, a stable disease rate of 55% with 21% of patients experiencing disease progression during treatment. This means that out of 100 patients treated with this drug, 24% saw their cancer shrink, 55% saw their cancer stay the same, and 21% saw their cancer grow."

Answered by AI

Does Navelbine cause neuropathy?

"The most common adverse reactions to NAVELBINE when used as a single agent include low white blood cell count, low neutrophil count, low hemoglobin, increased AST, nausea, vomiting, constipation, fatigue, reaction at the injection site, and peripheral neuropathy."

Answered by AI

What is Navelbine used to treat?

"Vinorelbine is a chemotherapy drug used for the treatment of breast cancer. Navelbine is the brand name for this drug."

Answered by AI

Clinical Trials for Navelbine

Image of University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center in Cleveland, United States.

Pulmonary Rehabilitation for Lung Cancer

18+
All Sexes
Cleveland, OH

This study is for people who have previously been diagnosed with advanced stage non-small cell lung cancer (NSCLC). Many people with advanced stage NSCLC have trouble breathing and feel tired. People may be eligible for this study if they have advanced stage NSCLC and feel short of breath some of the time. NSCLC survivors may also experience things like fatigue and a lower quality of life. Pulmonary rehabilitation is a type of supportive treatment that may improve these symptoms. This study has two parts. The first part is a randomized trial where half of the participants receive eight weeks of pulmonary rehabilitation. The other half of participants do not do pulmonary rehabilitation and instead receive the treatment that their doctors would normally recommend. The purpose of this part of the research study is to understand if pulmonary rehabilitation can help people with advanced stage NSCLC have better functioning and less shortness of breath. The other part of the research study is an interview study. The purpose of doing interviews is to understand any challenges or obstacles that people with advanced stage NSCLC may have regarding pulmonary rehabilitation, as well as oncology care providers have with their participants going to pulmonary rehabilitation.

Phase 2
Recruiting

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Melinda Hsu, MD, MS

Have you considered Navelbine clinical trials?

We made a collection of clinical trials featuring Navelbine, we think they might fit your search criteria.
Go to Trials

Have you considered Navelbine clinical trials?

We made a collection of clinical trials featuring Navelbine, we think they might fit your search criteria.
Go to Trials
Image of BRCR Medical Center, Inc. in Plantation, United States.

Virus Therapy and Chemotherapy for Lung Cancer

18+
All Sexes
Plantation, FL

This Phase 2, open-label, randomized study in non-small-cell lung cancer (NSCLC) is designed to evaluate the efficacy and safety of an intravenously delivered oncolytic vaccinia virus, Olvi-Vec, followed by platinum-doublet chemotherapy + Physician's Choice of Immune Checkpoint Inhibitor (ICI) vs. docetaxel for patients with advanced or metastatic NSCLC who have shown first disease progression (i.e., progressive disease not yet confirmed by further scan after initial scan showing progression) while on front-line treatment or maintenance ICI therapy after front-line treatment with platinum-doublet chemotherapy + ICI as standard of care.

Phase 2
Recruiting

BRCR Medical Center, Inc. (+15 Sites)

Newsoara Biopharma Co., Ltd.

Image of Lombardi Comprehensive Cancer Center, Georgetown University in Washington, United States.

Chemo-Immunotherapy for Lung Cancer

18+
All Sexes
Washington, United States

The goal of this clinical trial is to learn about neoadjuvant cemiplimab with histology-specific chemotherapy followed by resection and adjuvant cemiplimab in stage 3 non-small cell lung cancer (NSCLC) with contralateral mediastinal or ipsilateral supraclavicular lymph node (N3) involvement.. The main question it aims to answer is whether patients with stage 3 NSCLC with involvement of lymph nodes can undergo surgery to remove the cancer after receiving treatment with chemotherapy + immunotherapy. Participants will receive FDA-approved chemotherapy called platinum-doublet chemotherapy together with an immunotherapy drug targeting the immune marker PD-1 called cemiplimab. Patients will receive a 3 drug combination for 4 total treatments given every 3 weeks before surgery. After surgery, patients will have the option to undergo radiation therapy if it is recommended by their treatment team. After this, they will receive cemiplimab every 3 weeks for one year.

Phase 2
Recruiting

Lombardi Comprehensive Cancer Center, Georgetown University (+3 Sites)

Joshua Reuss, MD

Regeneron Pharmaceuticals

Have you considered Navelbine clinical trials?

We made a collection of clinical trials featuring Navelbine, we think they might fit your search criteria.
Go to Trials