ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Histologically or cytologically documented Stage IV or unresectable Stage III melanoma
- Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to NCI CTCAE Version 3.0 grade less than or equal to 1
- Adequate organ function as defined by the following criteria:
1. Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) less than or equal to 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
2. Total serum bilirubin less than or equal to 1.5 x ULN
3. Absolute neutrophil count (ANC) greater than or equal to 1500/mcL
4. Platelets greater than or equal to 100,000/mcL
5. Hemoglobin greater than or equal to 9.0 g/dL
6. Serum calcium less than or equal to 12.0 mg/dL
7. Serum creatinine less than or equal to 1.5 x ULN
- Patients with CNS metastasis must have had either:
1. Resected CNS metastasis without evidence of recurrence for >12 weeks
2. Brain metastasis treated by stereotactic radiosurgery without evidence of recurrence or progression for 12 weeks
3. Multiple brain lesions treated with WBRT with stable disease off corticosteroids for at least 12 weeks prior to start of therapy
4. Without any evidence of leptomeningeal disease
5. Patients must be neurologically intact
- May have previous adjuvant therapy with interferon, vaccines or therapy with IL-2 or GM-CSF
- Measurable disease by RECIST criteria
- In the phase I part of the trial patients with evaluable but not measurable disease may be allowed with the permission of the PI
- ECOG PS 0-2
- Major surgery or radiation therapy within 4 weeks of starting the study treatment.
- NCI CTCAE grade 3 hemorrhage within 4 weeks of starting the study treatment.
- History of or known carcinomatous meningitis, or evidence of symptomatic
leptomeningeal disease on screening CT or MRI scan.
- Any of the following within the 6 months prior to study drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, symptomatic congestive heart failure, cerebrovascular accident or transient
ischemic attack, or pulmonary embolism.
- Ongoing cardiac dysrhythmias of NCI CTCAE grade greater than or equal to 2.
- QTc >470 msec on baseline EKG.
- History of active CHF or LVEF<50% at screening echocardiogram.
- Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal
medical therapy).
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
the normal range with medication.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
(AIDS)-related illness or other active infection.
- Concurrent treatment on another clinical trial. Supportive care trials or
non-treatment trials, e.g. QOL, are allowed.
- Ongoing treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg po
daily for thromboembolism prophylaxis is allowed).
- Pregnancy or breastfeeding. Female subjects must be surgically sterile or be
postmenopausal, or must agree to use effective contraception during the period of
therapy. All female subjects with reproductive potential must have a negative
pregnancy test (serum or urine) prior to enrollment. Male subjects must be surgically
sterile or must agree to use effective contraception during the period of therapy. The
definition of effective contraception will be based on the judgment of the principal
investigator or a designated associate.
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or study
drug administration, or may interfere with the interpretation of study results, and in
the judgment of the investigator would make the subject inappropriate for entry into
this study.
- Patients may not have had previous treatment with a DTIC or temozolomide based
chemotherapy regimen. In the Phase II part of the trial patients may not have had
treatment with any chemotherapy regimen.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Birmingham, Alabama
- Birmingham, Alabama
- Birmingham, Alabama
- Birmingham, Alabama
- Fayetteville, Arkansas
- Rogers, Arkansas
- Orange County, California
- Orange, California
- Orange, California
- Aurora, Colorado
- Boulder, Colorado
- Colorado Springs, Colorado
- Denver, Colorado
- Lakewood, Colorado
- Parker, Colorado
- Pueblo, Colorado
- Chicago, Illinois
- Chicago, Illinois
- Chicago, Illinois
- Chicago, Illinois
- Goshen, Indiana
- Goshen, Indiana
- Grand Rapids, Michigan
- Grand Rapids, Michigan
- Grand Rapids, Michigan
- Jackson, Mississippi
- Jackson, Mississippi
- Hackensack, New Jersey
- Rochester, New York
- Dallas, Texas
- Burlington, Vermont
- Burlington, Vermont
- Burlington, Vermont
- Alexandria, Virginia
- Arlington, Virginia
- Fairfax, Virginia
- Fairfax, Virginia
- Fairfax, Virginia
- Falls Church, Virginia
- Gainesville, Virginia
- Leesburg, Virginia
- Woodbridge, Virginia
- Wenatchee, Washington
- Caba, Buenos Aires
- Buenos Aires, Ciudad Autónoma DE Buenosaires
- Buenos Aires, Ciudad Autónoma DE Buenosaires
- Buenos Aires, Ciudad Autónoma DE Buenosaires
- Buenos Aires, Ciudad Autónoma DE Buenosaires
- Buenos Aires, Ciudad Autónoma DE Buenosaires
- Buenos Aires, Ciudad Autónoma DE Buenosaires
- Gateshead, New South Wales
- Southport, Queensland
- Southport, Queensland
- Southport, Queensland
- Woolloongabba, Queensland
- Prahran, Victoria
- Nedlands, Western Australia
- Recife, Pernambuco
- Ijuí, RIO Grande DO SUL
- Porto Alegre, RIO Grande DO SUL
- Barretos, SAO Paulo
- Natal,
- Rio de Janeiro,
- Sao Paulo,
- Calgary, Alberta
- Toronto, Ontario
- Toronto, Ontario
- Toronto, Ontario
- Montreal, Quebec
- Montreal, Quebec
- Montreal, Quebec
- Montreal, Quebec
- Québec, Quebec
- Bogotá, Distrito Capital DE Bogotá
- Bogotá, Pbx (57-1)
- Brno, Jihomoravský KRAJ
- Praha 10, Praha, Hlavní Mesto
- Praha 2, Praha, Hlavní Mesto
- Brno,
- Olomouc,
- Ostrava Poruba,
- Praha,
- Nice, Alpes-maritimes
- Bordeaux, Gironde
- Grenoble, Isère
- Reims, Marne
- Lille, Nord
- Lyon, Rhone
- Lyon, Rhône
- Le Mans, Sarthe
- Villejuif, Val-de-marne
- Boulogne-Billancourt,
- Lille,
- Lyon,
- Nice,
- Paris,
- Paris,
- Paris,
- Paris,
- Pierre-bénite,
- Strasbourg,
- Templemars,
- Villejuif,
- Freiburg im Breisgau, Baden-württemberg
- Heidelberg, Baden-württemberg
- Mannheim, Baden-württemberg
- Tübingen, Baden-württemberg
- Ulm, Baden-württemberg
- München, Bayern
- Regensburg, Bayern
- Regensburg, Bayern
- Würzburg, Bayern
- Frankfurt, Hessen
- Kassel, Hessen
- Kassel, Hessen
- Buxtehude, Niedersachsen
- Buxtehude, Niedersachsen
- Bonn, Nordrhein-westfalen
- Minden, Nordrhein-westfalen
- Minden, Nordrhein-westfalen
- Mainz, Rheinland-pfalz
- Magdeburg, Sachsen-anhalt
- Dresden, Sachsen
- Leipzig, Sachsen
- Berlin, Schleswig-holstein
- Luebeck, Schleswig-holstein
- Lübeck, Schleswig-holstein
- Berlin,
- Bonn,
- Bonn,
- Dresden,
- Dresden,
- Erfurt,
- Erfurt,
- Essen,
- Freiburg,
- Gera,
- Gera,
- Gera,
- Hamburg,
- Hannover,
- Hannover,
- Hannover,
- Heidelberg,
- Homburg,
- Kiel,
- Lübeck,
- Magdeburg,
- Magdeburg,
- Mainz,
- Mannheim,
- Minden,
- Münster,
- Nürnberg,
- Regensburg,
- Tübingen,
- Ulm,
- Ulm,
- Athens, Attiki
- Athens,
- Athens,
- Piraeus,
- Budapest,
- Budapest,
- Debrecen,
- Szolnok,
- Ramat Gan, Tel-aviv
- Haifa,
- Jerusalem,
- Torrette Site, Ancona
- Napoli, Campania
- Roma, Lazio
- Roma, Lazio
- Lecco, Lombardia
- Milan, Lombardia
- Monza, Lombardia
- Rozzano, Lombardia
- Rozzano, Lombardia
- Candiolo, Torino
- Pisa, Toscana
- Terni, Umbria
- Padua, Veneto
- Bari,
- Bergamo,
- Bologna,
- Genoa,
- Milano,
- Napoli,
- Padova,
- Pavia,
- Ragusa,
- Siena,
- Torino,
- Fukuoka-shi, Fukuoka
- Matsumoto, Nagano
- Chuo-ku, Tokyo
- Niigata,
- Osaka, Ôsaka
- Gangnam-Gu, Seoul Teugbyeolsi
- Songpa-Gu, Seoul Teugbyeolsi
- Seoul,
- Seoul,
- Seoul,
- Seoul,
- Mexico,
- Mexico,
- Nijmegen, Gelderland
- Heerlen, Limburg
- Amsterdam, Noord Holland
- Breda, Noord-brabant
- Eindhoven, Noord-brabant
- Veldhoven, Noord-brabant
- Zwolle, Overijssel
- Enschede,
- Groningen,
- Leiden,
- Maastricht,
- Rotterdam,
- Rotterdam,
- Sittard-Geleen,
- Oslo,
- Oslo,
- Oslo,
- Warsaw, Mazowieckie
- Warszawa, Mazowieckie
- Warszawa,
- Lisbon, Lisboa
- Porto, Proto
- Almada,
- Lisboa,
- Lisboa,
- Lisboa,
- Porto,
- Moscow,
- St. Petersburg,
- Singapore,
- Singapore,
- Singapore,
- Bratislava,
- Bratislava,
- Bratislava,
- Poprad,
- Pretoria,
- Pretoria,
- Jerez De La Frontera, Andalucía
- Oviedo, Asturias
- Barcelona, Cataluña
- El Palmar, Murcia
- Pamplona, Navarra
- Pamplona, Navarra
- Alicante,
- Badalona,
- Barcelona,
- Barcelona,
- Barcelona,
- Barcelona,
- Donostia-san Sebastián,
- Dos Hermanas,
- Granada,
- La Coruna,
- Lleida,
- Lleida,
- Madrid,
- Madrid,
- Madrid,
- Madrid,
- Majadahonda,
- Malaga,
- Sevilla,
- Sevilla,
- Sevilla,
- Valencia,
- Göteborg,
- Lund,
- Solna,
- Uppsala,
- Zurich, Zürich (DE)
- Bern,
- Zürich,
- Zürich,
- Zürich,
- Bornova,
- Izmir,
- Izmir,
- Cambridge, Cambridgeshire
- Preston, Lancashire
- London, London, CITY OF
- Guildford, Surrey
- Bebington, Wirral
- Sheffield, York
- Broomfield,
- Leeds,
- London,
- Manchester,
- Oxford,
- Oxford,
- New York, New York
- Tampa, Florida
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | A Phase I/II Study of Sunitinib and Dacarbazine | |||
Official Title ICMJE | A Phase I/II Study of Sunitinib and Dacarbazine in Patients With Metastatic Melanoma | |||
Brief Summary | This is a combination Phase I/II design that explores the toxicity and activity of Sunitinib and Dacarbazine (DTIC) for metastatic melanoma. The initial Phase I part of this trial will consist of a dose escalation of sunitinib while keeping the DTIC dose constant. If no DLT is seen, this dose will be the suggested Phase II trial dose. If less than 2 disease responses are seen, patients will not be enrolled any further, and the study will be considered negative for activity. If a clinical response is seen, patients will continue to be enrolled. | |||
Detailed Description | This is a combination Phase I/II design that explores the toxicity and activity of a combination of sunitinib and Dacarbazine (DTIC) for metastatic melanoma. Screening tests (pre-study) will consist of a history, physical, CBC, CMP, EKG, pregnancy test for women of childbearing age, amylase (blood test for diagnoses of pancreatitis or other pancreatic diseases), staging CT, and PK. Also, on day 1, these tests will be repeated - a history, physical, toxicity assessment, CBC, and amylase test. Re-staging tests will be performed after 2 complete cycles and follow up as indicated clinically. The initial Phase I part of this trial will consist of a dose escalation of sunitinib while keeping the DTIC dose constant. Sunitinib will be given 2 weeks on and 1 week off with DTIC given once every 21 days for one cycle. If no DLT is seen, the maximum tolerated sunitinib dose will be the suggested as the Phase II trial dose. Tumor response will be measured after 2 complete cycles. Subsequently, during Phase II the trial will enroll more patients; if less than 2 responses are seen, patients will not be enrolled any further, and the study will be considered negative for activity. But, if a clinical response is seen, more patients will be enrolled at the Phase II dose. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Melanoma | |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Experimental: 1
Interventions:
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 11 | |||
Original Estimated Enrollment ICMJE | 53 | |||
Actual Study Completion Date ICMJE | June 2007 | |||
Actual Primary Completion Date | June 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00496223 | |||
Other Study ID Numbers ICMJE | MCC-14743 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Adil Daud, M.D., UCSF (formerly at H. Lee Moffitt Cancer Center & Research Institute) | |||
Study Sponsor ICMJE | H. Lee Moffitt Cancer Center and Research Institute | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | H. Lee Moffitt Cancer Center and Research Institute | |||
Verification Date | February 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |