Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma

Malignant Melanoma Clinical Trial

— SICOG 0109  

Official title:

Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma: Phase III Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359956
• Other study ID #: SICOG 0109
• Status: Completed
• Phase: Phase 3
• Start date: April 2002
• Est. completion date: February 2011

Study information

• Verified date: September 2020
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluated two chemotherapy regimens with and without the addition of interferon in patients with advanced or recurrent melanoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed diagnosis of malignant melanoma in advanced stage or recurrent after surgery, and not amenable to further surgery or local therapy.

• Presence of measurable disease

• Age > or = 18 years and < or = 75 years

• Performance status (ECOG) 0 - 2 (Appendix 2)

• Life expectancy ³ 3 months

• Adequate bone marrow function (ANC ³ 2,000/mmc; PTL ³ 100,000/mmc; Hb ³ 10 gr/dl), normal liver and renal function (bilirubin < 1.25 x N, creatinine < 1.25 x N, SGOT, SGPT < 3 times upper normal limit of testing laboratory.

• Written, informed consent prior to study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

• Prior surgery > 3 weeks from initiating .

• If palliative radiation is needed, in case of non target lesions, it must be given prior to initiating chemotherapy. If palliative radiation is required during the study the patient should be permanently discontinued from further treatment.

• Adequate contraceptive measures during study participation for sexually active patients of child bearing potential must implement.

Exclusion Criteria:

• Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin.

• Prior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed)

• Known HIV disease.

• Concurrent treatment with other experimental drugs.

• Concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy

• Pregnant or lactating females Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin.

Prior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed) Known HIV disease. Concurrent treatment with other experimental drugs. Concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma
• Recurrent Melanoma

Intervention

Drug:
• Dacarbazine
900 mg / m2 every 3 weeks
• Fotemustine
100 mg / m2 every 3 weeks
• Interferon Alfa-2b
5 M units every 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

References & Publications (1)

Daponte A, Signoriello S, Maiorino L, Massidda B, Simeone E, Grimaldi AM, Caraco C, Palmieri G, Cossu A, Botti G, Petrillo A, Lastoria S, Cavalcanti E, Aprea P, Mozzillo N, Gallo C, Comella G, Ascierto PA; Southern Italy Cooperative Oncology Group (SICOG) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Overall Survival was defined as the time from the date of randomisation to the date of death from any cause or the date of last follow-up for living patients.; OS curves were estimated with the Kaplan - Meier (K-M) method and treatments were compared with a two - sided log - rank test.	24 months
Secondary	Progression Free Survival (PFS)	Progression Free Survival (PFS) was defined as the time from the date of randomisation to the date of progression of disease or death from any cause, whichever occurred first, or date of last follow-up for patients without progression and alive at the end of the study.; PFS curves were estimated with the Kaplan - Meier (K-M) method and treatments were compared with a two-sided log-rank test.	12 months
Secondary	Overall Response Rate (ORR)	Overall Response Rate (ORR) included Complete Response (CR) and Partial Response (PR).; Complete Response (CR) was defined as disappearance of all symptoms and signs of all measurable disease, lasting for at least four weeks, without appearance of new lesions.; Partial Response (PR) was defined as a > 50% reduction in the sum of the products of the perpendicular diameters of all measurable lesions, lasting for at least four weeks, without appearance of new lesions or enlargement of existing lesions.	18 weeks from start of therapy
Secondary	Treatment Related Toxicity	worst grade CTC toxicity, for each cycle and overall, will be reported for each treatment arm	at end of each 3 week cycle of therapy up to the discontinuation