Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00576654 : Veliparib and Irinotecan Hydrochloride in Treating Patients With Cancer That Is Metastatic or Cannot Be Removed by Surgery
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Patients must have histologically or cytologically confirmed diagnosis of malignancy
that is metastatic or unresectable and for which standard curative or palliative
measures do not exist or are no longer effective or for whom CPT-11 treatment would
be a viable therapy regimen; patients with solid hematologic malignancies (Hodgkin's
and non-Hodgkin's lymphomas) may be included as long as a bone marrow has been
performed within 6 weeks of treatment

- Patients enrolled on the expansion portion of the study will consist of two cohorts:
those patients who are triple-negative, breast cancer (BRCA)-mutant positive and
those patients who have triple-negative, non-BRCA mutated breast cancer

- Patients enrolled on the dose escalation for intermittent ABT-888 portion of the
study must histologically or cytologically confirmed diagnosis of malignancy that is
metastatic or unresectable and for which standard curative or palliative measures do
not exist or are no longer effective or for whom CPT-11 treatment would be a viable
therapy regimen; patients with solid hematologic malignancies (Hodgkin's and
non-Hodgkin's lymphomas) may be included as long as a bone marrow has been performed
within 6 weeks of treatment; once the recommended phase 2 dose is determined,
additional patients will be enrolled who MUST have a deleterious mutation in BRCA and
have human epidermal growth factor receptor 2 (Her-2) negative, estrogen receptor
(ER) negative (defined as less than 1% ER by immunohistochemistry [IHC]) and
progesterone receptor (PR) negative breast cancer (defined as less than 1% PR
staining by IHC)

- Patient must have measurable disease per Response Evaluation Criteria in Solid Tumors
(RECIST) guidelines

- Patients must have tumors determined to be easily accessible for biopsy (e.g.
pleural-based lesions, peripheral lymph nodes, soft tissue metastases, large liver
metastases, etc)

- Patients must not be homozygous for the UGT1A1*28 allele (also called [TA]7);
individuals who are carriers for the UGT1A1*28 allele may be at increased risk for
neutropenia following initiation of irinotecan treatment

- Prior chemotherapy is allowed; patients must not have received chemotherapy for 4
weeks prior to the initiation of study treatment and must have full recovery from any
acute effects of any prior chemotherapy; patients must not have had nitrosoureas or
mitomycin C for 6 weeks prior to the initiation of study treatment

- Prior radiation therapy is allowed; patients must not have received minimal radiation
therapy (=< 5% of their total marrow volume) within 3 weeks prior to the initiation
of study treatment; otherwise, patients must not have received radiation therapy (>
5% of their total marrow volume) within 4 weeks prior to the initiation of study
treatment; patients who have received prior radiation to 50% or more of their total
marrow volume will be excluded

- Prior experimental (non-Food and Drug Administration [FDA] approved) therapies and
immunotherapies are allowed; patients must not have received these therapies for 4
weeks prior to the initiation of study treatment and must have full recovery from any
acute effects of these therapies

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

- Life expectancy of greater than 12 weeks

- Absolute neutrophil count (ANC) >= 1,500/mcL

- Platelets (PLT) >= 100,000/mcL

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper
limit of normal (ULN); if liver metastases are present, =< 5 x ULN

- Bilirubin =< 1.5 x ULN

- Creatinine =< 1.5 x ULN OR calculated or measured creatinine clearance >= 60
mL/min/1.73 m^2 for patients with creatinine above institutional normal

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry, for
the duration of study participation, and for three months following completion of
study therapy; should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately

- Ability to understand and the willingness to sign a written informed consent document

- All patients must provide archival tissue block or paraffin sample from archival
tissue block (approximately 10 sections) for use in pharmacodynamic correlative
studies (NOT required for patients enrolled on the dose escalation for intermittent
ABT-888 portion of the study)

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier;
patients who have been administered ABT-888 as part of a single or limited dosing
study, such as a phase 0 study, should not necessarily be excluded from participating
in this study solely because of receiving prior ABT-888

- Patients may not have received any other investigational agents within 4 weeks of
study entry

- History of allergic reactions attributed to the following:

- Camptothecin derivatives (e.g., topotecan [topotecan hydrochloride], irinotecan,
or exatecan [exatecan mesylate])

- Any ingredients contained within the liquid irinotecan solution (e.g., sorbitol)
or

- Any antiemetics or antidiarrheals appropriate for administration with study
therapy (e.g., loperamide or dexamethasone)

- Patients must not receive any other anti-cancer therapy (cytotoxic, biologic,
radiation, or hormonal other than for replacement) while on this study except for
medications that are prescribed for supportive care but may potentially have an
anti-cancer effect (i.e. megestrol acetate, bisphosphonates); these medications must
have been started 1 month prior to enrollment on this study; in addition, men
receiving treatment for prostate cancer will be maintained at castrate levels of
testosterone by continuation of luteinizing-releasing hormone agonists

- Patients with active seizure or a history of seizure

- Patients with known active brain metastases should be excluded from this clinical
trial; patients with prior treated brain metastases are allowed, providing that they
were not accompanied by seizures and that a baseline brain magnetic resonance imaging
(MRI) scan prior to study entry demonstrates no current evidence of brain metastases;
all patients with central nervous system (CNS) metastases must be stable for > 3
months after treatment and off steroid treatment prior to study enrollment

- Any patient requiring chronic maintenance of white blood cell counts or granulocyte
counts through the use of growth factor support (e.g. Neulasta, Neupogen)

- Any patient requiring cytochrome P450 CYP3A4 isoform-inducing drugs (e.g. phenytoin,
phenobarbital, carbamazepine, rifampin, rifabutin, ketoconazole, St. John's wort)
will be excluded; CYP3A4-inducing drugs should be discontinued at least 2 weeks prior
to the first cycle of irinotecan

- Uncontrolled intercurrent illness including, but not limited to:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia or

- Psychiatric illness or social situations that would limit compliance with study
requirements

- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with ABT-888

- Patients who are unable to reliably tolerate and/or receive oral medications
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00576654      |      Link to official Clinicaltrials.gov listing
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