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Irinotecan Hydrochloride and Veliparib in Treating Patients With Cancer That Is Metastatic or Cannot Be Removed by Surgery

Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT00576654 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 08-121

 

This phase I trial is studying the side effects and best dose of irinotecan given together with ABT-888 in treating patients with metastatic or unresectable cancer. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. ABT-888 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving irinotecan together with ABT-888 may kill more cancer cells

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center, Massachusetts General Hospital

Overall PI:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Eunice Kwak, MD, Massachusetts General Hospital
Bruce Dezube, MD, Beth Israel Deaconess Medical Center

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu

Eligibility Criteria

Inclusion Criteria: - Bilirubin =" 1.5 times ULN - Patients must have tumors determined to be easily accessible for biopsy (e.g. pleural-based lesions, peripheral lymph nodes, soft tissue metastases, or large liver metastases) - Archival tissue block or paraffin sample from archival tissue block (approximately 10 sections) for use in pharmacodynamic correlative studies must be available - No known active brain metastases - Patients with previously treated brain metastases are eligible, provided they are not accompanied by seizures and a baseline brain MRI scan demonstrates no current evidence of brain metastases - ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% - Life expectancy > 12 weeks - Absolute neutrophil count >= 1,500/mm^3 - Platelet count >= 100,000/mm^3 - AST and ALT =" 2.5 times upper limit of normal (ULN) (=" 5 times ULN if liver metastases are present) - Alkaline phosphatase =" 2.0 times ULN (=" 5 times ULN if bone or liver metastases are present) - Creatinine =" 1.5 times ULN OR creatinine clearance >= 60 mL/min - Ability to understand and the willingness to sign a written informed consent document - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception prior to, during, and for 3 months after completion of study treatment - Must be able to reliably tolerate and/or receive oral medications - No history of allergic reactions attributed to the following: - Camptothecin derivatives (e.g., topotecan hydrochloride, irinotecan hydrochloride, or exatecan mesylate) - Any ingredients contained within the liquid irinotecan hydrochloride solution (e.g., sorbitol) - Any antiemetics or antidiarrheals appropriate for administration with study therapy (e.g., loperamide or dexamethasone) - No prior history of seizures - No uncontrolled intercurrent illness including, but not limited to: - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Psychiatric illness or social situations that would limit compliance with study requirements - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered - More than 3 weeks since prior minimal radiotherapy (i.e., =" 5% of total marrow volume) - More than 4 weeks since prior radiotherapy (i.e., > 5% of total marrow volume) - No prior radiotherapy to >= 50% of total marrow volume - Histologically or cytologically confirmed metastatic or unresectable malignancy meeting 1 of the following criteria: - Standard curative or palliative measures do not exist or are no longer effective - Irinotecan hydrochloride is considered to be a viable therapy regimen - Patients enrolled on the expansion portion of the study will consist of two cohorts: those patients who are triple-negative, BRCA-mutant positive and those patients who have triple-negative, non-BRCA mutated breast cancer - Patients with solid hematologic malignancies (Hodgkin or non-Hodgkin lymphoma) are eligible provided a bone marrow has been performed within 6 weeks of treatment - Measurable disease per RECIST guidelines - Patients must be negative for carrying the UGT1A1*28 allele (also called (TA)7) - More than 4 weeks since prior experimental (i.e., non-FDA approved) therapy or immunotherapy and recovered - Males receiving treatment for prostate cancer must be maintained at castrate levels of testosterone by continuation of luteinizing-releasing hormone agonists - No cytochrome P450 CYP3A4 isoform-inducing drugs (e.g. phenytoin, phenobarbital, carbamazepine, rifampin, rifabutin, ketoconazole, St. John's Wort) - No other investigational agents within 4 weeks of study entry - No chronic growth factor support (e.g., filgrastim [G-CSF], pegfilgrastim) for maintenance of white blood cell counts or granulocyte counts - No other concurrent anticancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except medications for supportive care that may potentially have an anticancer effect (i.e., megestrol acetate, bisphosphonates) started 1 month prior to study - Patients with active seizure or a history of seizure are excluded - 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 MRI scan prior to study entry demonstrates no current evidence of brain metastases; all patients with CNS metastases must be stable for > 3 months after treatment and off steroid treatment prior to study enrollment
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