Vinorelbine Clinical Trials

What Is Vinorelbine?

Vinorelbine is an FDA-approved medication for certain cancers. The specific mechanism of how vinorelbine works is not detailed in the provided trial descriptions. It is being investigated as a chemotherapy agent, often administered intravenously. Clinical trials for vinorelbine began on July 10, 2002, with the latest trial projected to conclude on April 16, 2026. So far, 426 trials have been conducted, enrolling a total of 68,186 participants. Of these, 31 trials are currently recruiting new participants, and 213 trials have been completed.

Uses and Conditions Under Study

Vinorelbine is primarily studied for various types of cancer, either alone or in combination with other treatments. The most extensively studied conditions include:

• Breast Cancer: This includes Breast Cancer (86 trials), Metastatic Breast Cancer (34 trials), and Breast Neoplasms (10 trials), totaling 130 trials. Vinorelbine is investigated as a chemotherapy option, sometimes in combination with other agents like trastuzumab, for both early-stage and advanced disease.
• Lung Cancer: Vinorelbine is under investigation for various forms of lung cancer, including Lung Cancer (37 trials), Non Small Cell Lung Cancer (19 trials), Carcinoma, Non-Small-Cell Lung (12 trials), Non-Small Cell Lung Cancer (10 trials), and Non-small Cell Lung Cancer (8 trials), making up 86 trials. It is explored as a treatment for patients with metastatic disease or those who have progressed after initial therapies.
• Lymphoma: This blood cancer is being studied in 10 trials involving vinorelbine. It has been used in patients with diffuse large B-cell lymphoma who have not responded to second-line treatments.
• Prostate Cancer: Vinorelbine is also being investigated for Prostate Cancer in 9 trials.

These studies aim to evaluate vinorelbine's effectiveness and safety across different cancer types and treatment settings.

Dosing

Vinorelbine has been studied in both intravenous (IV) injection/infusion and oral forms. For intravenous administration, one studied dosage involves 6 mg/kg given via infusion on Day 1 of each 21-day cycle. Another intravenous regimen observed is 25 mg/m² weekly. Oral forms of vinorelbine have also been investigated, including "Metronomic Oral Vinorelbine," which typically refers to a continuous, low-dose regimen. Vinorelbine is often studied in combination with other chemotherapy agents or targeted therapies, with specific dosages tailored to the treatment regimen and the condition being studied.

Side Effects

In clinical trials, patients taking Vinorelbine experienced various side effects. The most common side effect was neutropenia, a decrease in a type of white blood cell.

• Neutropenia: 80.7% of patients taking Vinorelbine experienced neutropenia, compared to 69.5% on placebo.
• Stomatitis (mouth sores): 62.1% of patients on Vinorelbine experienced stomatitis, compared to 27.7% on placebo.
• Anemia (low red blood cell count): 48.0% of patients on Vinorelbine experienced anemia, compared to 29.9% on placebo.
• Leukopenia (low white blood cell count): 43.4% of patients on Vinorelbine experienced leukopenia, compared to 35.6% on placebo.
• Pyrexia (fever): 38.2% of patients on Vinorelbine experienced pyrexia, compared to 23.0% on placebo.
• Decreased appetite: 33.6% of patients on Vinorelbine experienced decreased appetite, compared to 17.4% on placebo.
• Diarrhea: 36.0% of patients on Vinorelbine experienced diarrhea, compared to 31.1% on placebo.
• Cough: 28.7% of patients on Vinorelbine experienced cough, compared to 19.4% on placebo.

Other reported side effects included fatigue, which affected 43.6% of patients on Vinorelbine and 43.3% on placebo. Nausea was reported in 36.0% of patients on Vinorelbine, compared to 37.7% on placebo.

Clinical Trial Results

Recurrent Brain Metastases

In a study (NCT00026494) investigating Vinorelbine and temozolomide in patients with recurrent brain metastases, radiographic responses were assessed. This was a dose-finding study where responses were observed across different Vinorelbine doses. For instance, responses were noted in 5 participants at the 15 mg/m² dose, 4 at 20 mg/m², 16 at 25 mg/m², and 16 at the 30 mg/m² dose. Specific response rates as percentages could not be determined from the available data.

Stage IV Breast Cancer (Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim Combination)

A clinical trial (NCT00041067) evaluated a combination regimen including Vinorelbine, trastuzumab, docetaxel, and filgrastim in women with Stage IV breast cancer. Key findings included:

• The median progression-free survival was 20 months.
• The 1-year survival rate was 93% of patients.
• A total of 53 participants showed a complete or partial response to treatment.

Stage IV Breast Cancer (Paclitaxel, Vinorelbine, and GCSF Combination)

Another study (NCT00041470) explored a regimen of weekly paclitaxel, Vinorelbine, and GCSF in patients with Stage IV breast cancer. Responses were observed in a total of 38 participants, though specific response rates as percentages could not be determined from the available data.

Stage IVB, Recurrent, or Persistent Cervical Cancer (Vinorelbine and Cisplatin Combination)

In a comparative study (NCT00064077) of different chemotherapy regimens for advanced cervical cancer, one arm used Vinorelbine combined with cisplatin. For patients in this arm:

• The median overall survival was 9.99 months.
• The median progression-free survival was 3.98 months.
• The overall response rate, based on RECIST criteria, was 50% (54 out of 108 evaluable patients).

Currently Recruiting Trials

Where to Participate

• St Louis, Missouri (9 sites)
• Cincinnati, Ohio (7 sites)
• New York, New York (7 sites)
• Houston, Texas (7 sites)
• Washington D.C., District of Columbia (6 sites)
• Phoenix, Arizona (6 sites)
• Irving, Texas (6 sites)
• Omaha, Nebraska (5 sites)
• Fargo, North Dakota (5 sites)
• Chicago, Illinois (5 sites)

Development Timeline