Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2018 |
| Start Date: | April 2003 |
| End Date: | August 2012 |
A Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in Patients With Metastatic Malignant Melanoma
This is a Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in subjects who
have metastatic melanoma which has advanced beyond the point at which local therapies such as
surgery or radiation therapy would be helpful. Without effective treatment, metastatic
melanoma is usually a severe and fatal disease. Chemotherapy agents or combinations of
chemotherapy agents have produced tumor shrinkage in some patients, which has occasionally
persisted. This research involves treatment with a combination of chemotherapy drugs known to
be active against melanoma alone. The investigational purpose of this study is to determine
if the combination of docetaxel, vinorelbine and sargramostim will produce a response
(complete or partial) in metastasis melanoma. The researchers also wants to find out what
side effects are associated with this combination of drugs.
have metastatic melanoma which has advanced beyond the point at which local therapies such as
surgery or radiation therapy would be helpful. Without effective treatment, metastatic
melanoma is usually a severe and fatal disease. Chemotherapy agents or combinations of
chemotherapy agents have produced tumor shrinkage in some patients, which has occasionally
persisted. This research involves treatment with a combination of chemotherapy drugs known to
be active against melanoma alone. The investigational purpose of this study is to determine
if the combination of docetaxel, vinorelbine and sargramostim will produce a response
(complete or partial) in metastasis melanoma. The researchers also wants to find out what
side effects are associated with this combination of drugs.
Annually in the U.S. there is an estimated 40,000 new cases of malignant melanoma and 7000
deaths. This disease is becoming more common with its incidence increasing at a more rapid
rate in the past decade than that of any other cancer except lung cancer in women. Metastatic
disease responds poorly to the usual treatments with only 2 out of 30 drugs tested, DTIC and
nitrosoureas, showing response rates greater than 10%. Complete responses are rare.
Metastatic melanoma is a disease with few therapeutic options. Multi-agent chemotherapy with
cisplatin (CDDP), Dacarbazine (DTIC), Carmustine (BCNU), with or without Tamoxifen, offers a
20% response rate but has failed to consistently demonstrate a significant improvement in
overall survival (OS) or disease-free survival (DFS) when compared to a single agent DTIC.
Recently, investigators, in an effort to combine the activity of biologic response modifiers
with chemotherapy, have developed combination biochemotherapy for metastatic melanoma. Legha
et al reported an overall objective response rate of 64% with a 5-day biochemotherapy
regimen. O'Day et al reported similar results (overall response rate of 57%) using a modified
5-day biochemotherapy regimen.
The above regimens all have significant toxicities and modest response rates. Clearly, more
effective less toxic regimens are needed.
Vinorelbine tartrate (Navelbine) and Docetaxel (Taxotere) have both shown activity against
melanoma. Additionally, the combination of both drugs has shown enhanced activity against
melanoma.
deaths. This disease is becoming more common with its incidence increasing at a more rapid
rate in the past decade than that of any other cancer except lung cancer in women. Metastatic
disease responds poorly to the usual treatments with only 2 out of 30 drugs tested, DTIC and
nitrosoureas, showing response rates greater than 10%. Complete responses are rare.
Metastatic melanoma is a disease with few therapeutic options. Multi-agent chemotherapy with
cisplatin (CDDP), Dacarbazine (DTIC), Carmustine (BCNU), with or without Tamoxifen, offers a
20% response rate but has failed to consistently demonstrate a significant improvement in
overall survival (OS) or disease-free survival (DFS) when compared to a single agent DTIC.
Recently, investigators, in an effort to combine the activity of biologic response modifiers
with chemotherapy, have developed combination biochemotherapy for metastatic melanoma. Legha
et al reported an overall objective response rate of 64% with a 5-day biochemotherapy
regimen. O'Day et al reported similar results (overall response rate of 57%) using a modified
5-day biochemotherapy regimen.
The above regimens all have significant toxicities and modest response rates. Clearly, more
effective less toxic regimens are needed.
Vinorelbine tartrate (Navelbine) and Docetaxel (Taxotere) have both shown activity against
melanoma. Additionally, the combination of both drugs has shown enhanced activity against
melanoma.
Inclusion Criteria:
- Age greater than or equal to 18
- Karnofsky Performance Status (KFS) of greater than or equal to 70
- Laboratory values (performed in 14 days, inclusive prior to study drug
administration):
- Absolute neutrophil count (ANC) >1500/mm3
- Platelet count >100,000/mm3
- Hemoglobin > 10 g/dl
- Blood urea nitrogen (BUN) and serum creatinine < 0.5 times the upper limit of
laboratory normal
- Total and direct bilirubin < 1.5 times the upper limit of laboratory normal
- Serum glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic
transaminase(SGPT) < 3 times the upper limit of laboratory normal
- Alkaline phosphatase < 3 times upper limit of laboratory normal
- Life expectancy of greater than 12 weeks
- Written informed consent
Exclusion Criteria:
- No recovery from all active toxicities of prior therapies
- Surgery within 1 week prior to study drug administration, providing acute surgical
toxicity is resolved
- Subjects within acute infection treated with intravenous antibiotics
- Frequent vomiting or medical condition that could interfere with oral medication
intake (e.g., partial bowel obstruction)
- Concurrent malignancies at other sites with the exception of surgically cured
carcinoma in situ (CIS ) of the cervix, basal or squamous cell carcinoma of the skin,
and prior malignancies which have not required anit-tumor treatment within the
preceding 24 months
- Known HIV-positivity or AIDS-related illness
- Women of childbearing potential who are not using an effective method of contraception
(eligible patients must have a negative urine pregnancy test 24 hours prior to
administration of study drug and be practicing medically approved contraceptive
precautions)
- Men who do not use an effective method of contraception.
- Chemotherapy within four weeks prior to study drug administration or biologic
therapy/immunotherapy within two weeks prior to study drug administration
- Completion of radiation therapy, interstitial brachytherapy, or radiosurgery within 4
weeks prior to study drug administration (patients with brain metastases from melanoma
must have completed radiotherapy to the brain at least 3 weeks before study commences)
- Bone metastases as sole reason for Stage IV disease
- Karnofsky Performance Status of less than or equal to 60
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