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Completed

NCT Number: NCT01359956

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

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

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Key information

Conditions

Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Recurrent Melanoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dacarbazine

Drug

900 mg / m2 every 3 weeks

fotemustine

Drug

100 mg / m2 every 3 weeks

Interferon Alfa-2b

Drug

5 M units every 3 weeks

Primary outcomes

  1. Overall Survival (OS)

    Time frame: 24 months

    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.

Secondary outcomes

  1. Progression Free Survival (PFS)

    Time frame: 12 months

    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.

  2. Overall Response Rate (ORR)

    Time frame: 18 weeks from start of therapy

    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.

  3. Treatment Related Toxicity

    Time frame: at end of each 3 week cycle of therapy up to the discontinuation

    worst grade CTC toxicity, for each cycle and overall, will be reported for each treatment arm

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Naples

Other

Registry information

Official study title

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

Acronym: SICOG 0109

Important dates

Study start
2002
Primary completion
2011
Study completion
2011
First posted
May 25, 2011
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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