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This study evaluated two chemotherapy regimens with and without the addition of interferon in patients with advanced or recurrent melanoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental | combination chemotherapy without interferon |
|
| A2 | Experimental | combination chemotherapy with interferon |
|
| B1 | Active Comparator | single agent dacarbazine without interferon |
|
| B2 | Experimental | single agent dacarbazine plus interferon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dacarbazine | Drug | 900 mg / m2 every 3 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Paolo A Ascierto, M.D., Ph.D. | NCI Naples | Principal Investigator |
| Antonio Daponte, M.D. | NCI Naples | Principal Investigator |
| Simona Signoriello, M.D. | University of Campania Luigi Vanvitelli | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23402397 | Result | 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). Phase III randomized study of fotemustine and dacarbazine versus dacarbazine with or without interferon-alpha in advanced malignant melanoma. J Transl Med. 2013 Feb 13;11:38. doi: 10.1186/1479-5876-11-38. |
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Patients were randomly assigned to one of four treatment groups. Patients were randomized through a computerized procedure of permuted blocks centralized at the coordinating center (Medical Oncology, NCI Napoli), stratified by PS (0-1,2) and site of metastases (visceral, not visceral).
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| ID | Title | Description |
|---|---|---|
| FG000 | A1 - Combination Chemotherapy Without Interferon | combination chemotherapy without interferon Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle |
| FG001 | A2 - Combination Chemotherapy With Interferon | combination chemotherapy with interferon Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle Interferon Alfa-2b: α2b 5 MUI three times per week |
| FG002 | B1 - Single Agent Dacarbazine Without Interferon | single agent dacarbazine without interferon Dacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle |
| FG003 | B2 - Single Agent Dacarbazine Plus Interferon | single agent dacarbazine plus interferon Dacarbazine: 900 mg / m2 every 3 weeks Interferon Alfa-2b: α2b 5 MUI three times per week |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A1 - Combination Chemotherapy Without Interferon | combination chemotherapy without interferon Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle |
| BG001 | A2 - Combination Chemotherapy With Interferon |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Nine patients were lost to follow-up immediately after randomization and, in particular, for FDI + FD 132, instead of 136 randomized (4 lost pts.), for DI + D, 128 instead of 133 (5 lost pts.), for FD1 + DI 126, instead of 131 (5 lost pts.), 134 instead of 138 (4 lost pts.) | Posted | Median | Full Range | Months | 24 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A1 - Combination Chemotherapy Without Interferon | combination chemotherapy without interferon Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paolo A Ascierto, M.D., Ph.D | NCI Naples | +39 081 5903431 | p.ascierto@istitutotumori.na.it |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| C054368 | fotemustine |
| D000077190 | Interferon alpha-2 |
| ID | Term |
|---|---|
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 |
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| Fotemustine |
| Drug |
100 mg / m2 every 3 weeks |
|
| Interferon Alfa-2b | Drug | 5 M units every 3 weeks |
|
| 12 months |
| 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 |
| 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 |
| Lost to Follow-up |
|
combination chemotherapy with interferon Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle Interferon Alfa-2b: α2b 5 MUI three times per week |
| BG002 | B1 - Single Agent Dacarbazine Without Interferon | single agent dacarbazine without interferon Dacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle |
| BG003 | B2 - Single Agent Dacarbazine Plus Interferon | single agent dacarbazine plus interferon Dacarbazine: 900 mg / m2 every 3 weeks Interferon Alfa-2b: α2b 5 MUI three times per week |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Nodular melanoma | Count of Participants | Participants |
|
| OG001 | Dacarbazine/Interferon + Dacarbazine | single agent dacarbazine plus interferon Dacarbazine: 900 mg / m2 every 3 weeks Interferon Alfa-2b: α2b 5 MUI three times per week single agent dacarbazine without interferon Dacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle |
| OG002 | Fotemustine/Dacarbazine/Interferon+Dacarbazine/Interferon | combination chemotherapy with interferon Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle Interferon Alfa-2b: α2b 5 MUI three times per week single agent dacarbazine plus interferon Dacarbazine: 900 mg / m2 every 3 weeks Interferon Alfa-2b: α2b 5 MUI three times per week |
| OG003 | Fotemustine/Dacarbazine + Dacarbazine | combination chemotherapy without interferon Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle single agent dacarbazine without interferon Dacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle |
|
|
| 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. | Nine patients were lost to follow-up immediately after randomization and, in particular, for FDI + FD 132, instead of 136 randomized (4 lost pts.), for DI + D, 128 instead of 133 (5 lost pts.), for FD1 + DI 126, instead of 131 (5 lost pts.), 134 instead of 138 (4 lost pts.). | Posted | Median | Full Range | Months | 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. | Nine patients were lost to follow-up immediately after randomization and, in particular, for FDI + FD 132, instead of 136 randomized (4 lost pts.), for DI + D 128, instead of 133 (5 lost pts.), for FD1 + DI 126, instead of 131 (5 lost pts.), 134, instead of 138 (4 lost pts.). | Posted | Number | participants | 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 | It wasn't possible to assess the treatment related toxicity for all the patients included in the study because for some of them, no data were collected. It's difficult to indicate the exact number of participants affected by the worst grade CTC toxicity because the same patient could be affected by one or more side effects. | Posted | Count of Participants | Participants | at end of each 3 week cycle of therapy up to the discontinuation |
|
|
|
| 14 |
| 62 |
| 12 |
| 62 |
| EG001 | A2 - Combination Chemotherapy With Interferon | combination chemotherapy with interferon Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle Interferon Alfa-2b: α2b 5 MUI three times per week | 27 | 67 | 25 | 67 |
| EG002 | B1 - Single Agent Dacarbazine Without Interferon | single agent dacarbazine without interferon Dacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle | 8 | 71 | 16 | 71 |
| EG003 | B2 - Single Agent Dacarbazine Plus Interferon | single agent dacarbazine plus interferon Dacarbazine: 900 mg / m2 every 3 weeks Interferon Alfa-2b: α2b 5 MUI three times per week | 10 | 52 | 13 | 52 |
| Platelets | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D016898 | Interferon-alpha |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |