Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.
DCRB
Skin - Melanoma
Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.
- For the treatment of patients with metastatic melanoma.
- For the treament of patients with metastatic leiomyosarcoma and liposarcoma
Doses should be modified according to the protocol by which the patient is being treated.
Dosage with toxicity
|
Toxicity |
Action1 |
Dose |
|
Grade 3 (with fever or systemic infection) or Grade 4 hematological toxicity |
Hold |
↓ 25% |
|
Grade 3 non-hematological |
Hold |
↓ 25%; discontinue if recurs after 2 dose reductions |
|
Grade 4 non-hematological |
Discontinue |
Not applicable
|
1Before retreatment, major organ toxicities should recover to ≤ Grade 2, platelets ≥ 100 x 109/L, and ANC ≥ 1.5 x 109/L.
Hepatic Impairment
Adjustment required; no details found.
Renal Impairment
|
Creatinine Clearance (mL/min) |
Dose* |
|
>50 |
100% of dose |
|
30-50 |
75% of dose |
|
10-30 |
50% or discontinue |
|
<10 |
discontinue |
* modified from Kintzel et al 1995
Dosage in the Elderly
Safety and efficacy not established.
Refer to dacarbazine drug monograph(s) for additional details of adverse effects
|
Very common |
Common (25-49%) |
Less common |
Uncommon (< 10%), but may be severe or life-threatening |
|
|
|
|
Refer to dacarbazine drug monograph(s) for additional details
Administration
-
Administration of concentrated dacarbazine solutions may cause severe perivenous pain; therefore, it is recommended to give dacarbazine as a diluted IV infusion.
-
Extreme care should be taken to avoid extravasation as this may result in tissue damage and severe pain.
-
May be mixed in 500 mL to 1000 mL normal saline or D5W bag and infused IV over 1 to 2 hours.
- Keep dacarbazine vials refrigerated (2 to 8ºC); protect the undiluted drug, infusion bags and tubing from light.
Contraindications
- patients with known hypersensitivity to dacarbazine, or any component of its formulation
- patients who have previously had severe myelosuppression.
Warnings/Precautions
- Dacarbazine is a moderate immunosuppressive agent. Avoid the use of live vaccines during treatment and for at least 3 months after the last dose. Response to inactivated vaccines may be decreased.
Pregnancy/Lactation:
- Dacarbazine is not recommended for use in pregnancy. Adequate contraception should be used by both sexes during therapy and for at least 6 months after treatment cessation.
- Breast feeding is not recommended due to the potential secretion into breast milk.
- Effects on fertility: Probable
Recommended Clinical Monitoring
- CBC; Baseline and before each cycle
- Liver and renal function tests; Baseline and as clinically indicated
- Clinical toxicity assessment including GI, infection, bleeding, hypersensitivity, skin, injection site reactions, flu-like symptoms; At each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Avril MF, Aamdal S, Grob JJ, et al. Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma: A phase III study. JCO 2004; 22:1118-25.
Therapy for metastatic malignant melanoma using high dose single agent dacarbazine. BC Cancer Agency, Feb 1, 2020.
Bedikian AY, Millward M, Pehamberge H, et al. Bcl-2 Antisense (oblimersen sodium) Plus Dacarbazine in Patients With Advanced Melanoma: The Oblimersen Melanoma Study Group. J Clin Oncol 2006; 24(29) 4738-45.
Chapman PB, Hauschild A, Robert C, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med 2011;364:2507-16.
Chapman PB, Einhorn LH, Meyers ML, et al. Phase III multicentre randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol 1999; 17(9): 2745-51. J Clin Oncol 2015;34:786-793.
Dacarbazine drug monograph, Cancer Care Ontario.
Demetri GD, von Mehren M, Jones RL, et al. Efficacy and safety of trabectedin or dacarbazine for metastatic liposarcoma or leiomyosarcoma after failure of conventional chemotherapy: results of a phase III randomized multicentre clinical trial.
Middleton MR, Grob JJ, Aaronson N, et al. Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol 2000; 18(1): 158-66.
Pritchard KI, Quirt IC, Cowan DH, et al. DTIC therapy in metastatic malignant melanoma: a simplified dose schedule. Cancer Treat Rep, 1980; 64: 1123-26.
Sileni VC, Nortilli R, Aversa SML, et al. Phase II randomized study of dacarbazine, carmustine, cisplatin and tamoxifen versus dacarbazine alone in advanced melanoma patients. Melanoma Research 2001; 11: 189-96.
August 2020 added liposarcoma and leiomyosarcoma as ST-QBP approved indications
Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
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