A Phase I/II Study of Sunitinib and Dacarbazine

NCT00496223

Last updated date
Study Location
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Melanoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
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
  • Drug: Sunitinib
    Sunitinib will be given PO once daily on days 1-14 of each 21 day cycle. The exact dose of sunitinib will be determined during the Phase I part of the trial.
  • Drug: Dacarbazine
    Dacarbazine will be given at 1000 mg/m2 on day 1 of every 21 day cycle.
    Other Name: DTIC
Study Arms  ICMJE Experimental: 1
Interventions:
  • Drug: Sunitinib
  • Drug: Dacarbazine
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
 (submitted: January 28, 2009)
11
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2007)
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:

  • 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

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Adil Daud, M.D.UCSF (formerly at H. Lee Moffitt Cancer Center & Research Institute)
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