A clinical trial of intravenous vinorelbine tartrate plus tamoxifen in the treatment of patients with advanced malignant melanoma

Lynn G. Feun, Niramol Savaraj, Judith Hurley, Angela Marini, Shenghan Lai

Research output: Contribution to journalArticle

Abstract

BACKGROUND. The aim of the current trial was to assess the efficacy and toxicity of weekly intravenous vinorelbine tartrate with daily oral tamoxifen in the treatment of patients with advanced or metastatic malignant melanoma. METHODS. Thirty-one patients were treated with vinorelbine tartrate, 30 mg/m2 intravenously, weekly every 13 weeks and then every 2 weeks thereafter until progression of disease or severity of toxicity warranted discontinuation. Tamoxifen, 10 mg orally, twice a day was administered daily starting on Day 1 of chemotherapy with vinorelbine tartrate. Thirty patients had cutaneous melanoma with metastases and 1 patient had ocular melanoma with metastases. Eight patients had received prior chemotherapy. RESULTS. Of the 30 evaluable patients with cutaneous melanoma, 6 achieved a partial response, for an overall response rate of 20% (95% confidence interval, 7-38%). There was no response in the patient with ocular melanoma. Major sites of response include the adrenal gland, lung, tonsil, and cutaneous/subcutaneous tissues. Three patients had a prolonged duration of response lasting ≥ 12 months. Side effects generally were mild and tolerable. Grade 3 or 4 hematologic toxicity occurred in 26% and 13% of patients, respectively. Nonhematologic toxicity included mild fatigue, paresthesia, and local arm discomfort from infusion. CONCLUSIONS. Weekly intravenous vinorelbine tartrate plus daily oral tamoxifen appears to be active in the treatment of patients with malignant melanoma. Further clinical trials in malignant melanoma patients treated with vinorelbine tartrate and tamoxifen appear warranted.

Original languageEnglish (US)
Pages (from-to)584-588
Number of pages5
JournalCancer
Volume88
Issue number3
DOIs
StatePublished - Feb 1 2000
Externally publishedYes

Fingerprint

Tamoxifen
Melanoma
Clinical Trials
Therapeutics
Skin
vinorelbine
Neoplasm Metastasis
Drug Therapy
Paresthesia
Palatine Tonsil
Subcutaneous Tissue
Adrenal Glands
Fatigue
Disease Progression
Confidence Intervals
Lung

Keywords

  • Efficacy
  • Melanoma
  • Tamoxifen
  • Toxicity
  • Vinorelbine tartrate

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

A clinical trial of intravenous vinorelbine tartrate plus tamoxifen in the treatment of patients with advanced malignant melanoma. / Feun, Lynn G.; Savaraj, Niramol; Hurley, Judith; Marini, Angela; Lai, Shenghan.

In: Cancer, Vol. 88, No. 3, 01.02.2000, p. 584-588.

Research output: Contribution to journalArticle

Feun, Lynn G. ; Savaraj, Niramol ; Hurley, Judith ; Marini, Angela ; Lai, Shenghan. / A clinical trial of intravenous vinorelbine tartrate plus tamoxifen in the treatment of patients with advanced malignant melanoma. In: Cancer. 2000 ; Vol. 88, No. 3. pp. 584-588.
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N2 - BACKGROUND. The aim of the current trial was to assess the efficacy and toxicity of weekly intravenous vinorelbine tartrate with daily oral tamoxifen in the treatment of patients with advanced or metastatic malignant melanoma. METHODS. Thirty-one patients were treated with vinorelbine tartrate, 30 mg/m2 intravenously, weekly every 13 weeks and then every 2 weeks thereafter until progression of disease or severity of toxicity warranted discontinuation. Tamoxifen, 10 mg orally, twice a day was administered daily starting on Day 1 of chemotherapy with vinorelbine tartrate. Thirty patients had cutaneous melanoma with metastases and 1 patient had ocular melanoma with metastases. Eight patients had received prior chemotherapy. RESULTS. Of the 30 evaluable patients with cutaneous melanoma, 6 achieved a partial response, for an overall response rate of 20% (95% confidence interval, 7-38%). There was no response in the patient with ocular melanoma. Major sites of response include the adrenal gland, lung, tonsil, and cutaneous/subcutaneous tissues. Three patients had a prolonged duration of response lasting ≥ 12 months. Side effects generally were mild and tolerable. Grade 3 or 4 hematologic toxicity occurred in 26% and 13% of patients, respectively. Nonhematologic toxicity included mild fatigue, paresthesia, and local arm discomfort from infusion. CONCLUSIONS. Weekly intravenous vinorelbine tartrate plus daily oral tamoxifen appears to be active in the treatment of patients with malignant melanoma. Further clinical trials in malignant melanoma patients treated with vinorelbine tartrate and tamoxifen appear warranted.

AB - BACKGROUND. The aim of the current trial was to assess the efficacy and toxicity of weekly intravenous vinorelbine tartrate with daily oral tamoxifen in the treatment of patients with advanced or metastatic malignant melanoma. METHODS. Thirty-one patients were treated with vinorelbine tartrate, 30 mg/m2 intravenously, weekly every 13 weeks and then every 2 weeks thereafter until progression of disease or severity of toxicity warranted discontinuation. Tamoxifen, 10 mg orally, twice a day was administered daily starting on Day 1 of chemotherapy with vinorelbine tartrate. Thirty patients had cutaneous melanoma with metastases and 1 patient had ocular melanoma with metastases. Eight patients had received prior chemotherapy. RESULTS. Of the 30 evaluable patients with cutaneous melanoma, 6 achieved a partial response, for an overall response rate of 20% (95% confidence interval, 7-38%). There was no response in the patient with ocular melanoma. Major sites of response include the adrenal gland, lung, tonsil, and cutaneous/subcutaneous tissues. Three patients had a prolonged duration of response lasting ≥ 12 months. Side effects generally were mild and tolerable. Grade 3 or 4 hematologic toxicity occurred in 26% and 13% of patients, respectively. Nonhematologic toxicity included mild fatigue, paresthesia, and local arm discomfort from infusion. CONCLUSIONS. Weekly intravenous vinorelbine tartrate plus daily oral tamoxifen appears to be active in the treatment of patients with malignant melanoma. Further clinical trials in malignant melanoma patients treated with vinorelbine tartrate and tamoxifen appear warranted.

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