Description:

Eligibility/Pre-Registration Worksheet ABT-888 With Cyclophosphamide in Refractory BRCA-Positive Ovarian, Primary Peritoneal or Ovarian High-Grade Serous Carcinoma, Fallopian Tube Cancer, Triple-Negative Breast Cancer, and Low-Grade Non-Hodgkin's Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=94CE0410-6594-C0F7-E040-BB89AD4342BD

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=94CE0410-6594-C0F7-E040-BB89AD4342BD

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  1. 8/27/12
  2. 1/9/15
Uploaded on:

January 9, 2015

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT01306032 Registration - Eligibility/Pre-Registration Worksheet - 3158687v1.0

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  1. StudyEvent: Eligibility/Pre-Registration Worksheet
    1. No Instruction available.
Standard Patient Identifier
Standard Demographics (ii)
Inclusion Criteria
Has histologically documented (confirmed by the department of pathology at the enrolling institution prior to patient registration) BRCA-positive ovarian cancer, primary peritoneal or ovarian high-grade serous carcinoma, fallopian tube cancer, triple-negative breast cancer with distant metastasis, or low-grade lymphoid malignancies (NHL) as specified below:
Indicate Cancer histology:
Has disease progressed following at least one line of standard therapy?
Has measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >=20 mm with conventional techniques or as >=10 mm with spiral CT scan?
Prior therapy completed >=4 weeks prior to enrollment on protocol (at least six weeks out from nitrosoureas and mitomycin C) and associated toxicities resolved to eligibility levels.
Prior radiation completed >=4 weeks prior to study enrollment, and associated toxicities resolved to eligibility levels.
At least 2 weeks since prior investigational agent administered as part of a Phase 0 study, and associated toxicities resolved to eligibility levels.
Age >= 18 years
Karnofsky Performance Status (>=70%, see Appendix A site to complete box with actual score)
Life expectancy >3 months
Absolute neutrophil count (ANC) >=1,500/mm^3
Platelet count >= 100,000/mm^3
Total bilirubin <= 1.5 x ULN
mg/dL
AST (SGOT) and ALT (SGPT) <= 2.5x institutional upper limits of normal
Creatinine < 1.5x institutional upper limits of normal OR Creatinine clearance >=60 mL/min for patients with creatinine levels >=1.5x institutional upper limit of normal.
Able to swallow whole capsule?
Exclusion Criteria
Has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirement?
Pregnant? ([Note: women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for 3 months after completion of study.])
Breastfeeding?
Has germ cell or borderline ovarian epithelial tumors
Has had seizure within last 3 months while on anti-seizure medication for CNS metastases
Has ulcerative colitis, inflammatory bowel disease, partial or complete small bowel obstruction, or other gastrointestinal condition that might predispose for drug intolerability or poor drug absorption (e.g., inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, malabsorption syndrome, and active peptic ulcer disease).
Has had prior treatment with any PARP inhibitors that were administered in combination with cyclophosphamide
Is receiving other investigational agents
Pre Study Evaluations
Does the patient have bone marrow involvement? (for lymphoma patients only, if "Yes" please provide date in the following question, select "NA" if patient is not a lymphoma patient)
Laboratory Studies Will Be Conducted 1 Week Prior To Starting Study Drug Will Include

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