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Details for trial 0C-07-7
Description:
A Phase I Study of ABT-888 in Combination with Carboplatin and Paclitaxel in Advanced Solid Malignancies.
Status:
Open
Randomized?
No
Researchers
Principal Investigator
Title
Heinz Josef Lenz
M.D.
Data Management
Name
Title
Claire Hughlett
R.N.
Mary Ordaz
D.M.
Anayansi Miloud
D.M.
Xiomara Menendez
R.N.
You may participate in this study if:
Requirement
1
Histologically or cytologically confirmed malignancy.
2
Two, or less, prior chemotherapy regimens. Adjuvant chemotherapy 2 yrs or more prior to enrollment not counted as "prior chemotherapy regimen" for purposes of this study.
3
18 y/o and above.
4
ECOG PS 0-2.
5
Life expectancy > 12 wks.
6
ANC 1500 or greater; Platelets 100,000 or greater.
7
Total bilirubin equal to or less than 1.5 x ULN. AST/ALT equal to or less than 2.5 x ULN.
8
Creatinine witnin normal or Creatinine Clearance 60 mL/min or greater, if creatinine > ULN.
9
Men & women of reproductive potential must agree to use adequate contraception (hormonal, barrier, abstinence) prior to, during & for at least 3 mos after study completion.
10
Signed Informed Consent, including HIPAA authorization.
You may not participate in this study if:
1
Chemotherapy or radiotherapy within 3 wks (6 wks for nitrosoureas or mitomycin C) prior to study.
2
Not recovered from toxicities due to agents administered > 3 wks earlier. Those who received ABT-888 as part of a single or limited dosing study, such as a Phase 0 study, will not necessarily be excluded solely because of receiving prior ABT-888.
3
Receiving any other investigational agents.
4
Known history of allergic reactions to ABT-888, carboplatin or cremophorpaclitaxel.
5
Prior Paclitaxel.
6
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness/social situations that would limit study compliance.
7
Pregnant women.
8
Peripheral neuropathy > Gr 1.
9
Inability to take oral medications on a continuous basis.
10
History of seizure disorder.
11
Evidence of bleeding diathesis.
12
Patients with brain metastases should have stable disease for at least 4 wks following treatment for brain metastases (such as surgery, radiation or stereotactic radiosurgery).
13
Patients who undergo biopsy as part of the study in the expanded dose cohort should not be on anti-coagulants or a pre-existing coagulopathy.
14
HIV positive patients on combination antiretroviral therapy. HIV positive patients without an AIDS-defining diagnosis & not receiving agents with potential for PK interactions with ABT-888 may be eligible.
For further information on, or to sign up for this study, please contact the Clinical Investigation Support Office at (323) 865-0451 or the Principal Investigator noted above.
