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Investigator(s):
Giuseppe Giaccone, M.D., Ph.D. Principal Investigator Phone: 301-496-4916 Fax: 301-402-0172 giacconeg@mail.nih.gov
Referral Contact(s):
Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 Fax: 301-451-5433 jbingham@mail.nih.gov	Mary Ann Yancey, R.N. Research Nurse Phone: 301-435-9227 yanceym@mail.nih.gov	Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-451-5433 ottenl@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed solid tumor malignancy
• Unresectable or metastatic disease for which standard curative measures do not exist, or are associated with minimal patient survival benefit
• Brain metastases allowed provided the brain metastases were previously treated and have remained stable for ≥ 3 months AND do not require steroids (except for maintenance replacement doses of steroids) or anti-seizure medications
• No known history of BRCA1 and BRCA2 mutations
• No lymphomas or primary CNS malignancies
• Recovered from prior therapy
• Prior cisplatin and/or gemcitabine hydrochloride allowed
• No concurrent chemotherapy, investigational agents, or other anticancer therapy
• ≥ 18 years of age
• ECOG performance status (PS) 0–2 or Karnofsky PS 60–100%
• Absolute neutrophil count ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
• AST/ALT ≤ 2.5 x ULN
• Creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing; fertile patients must use effective contraception before, during, and for 30 days after completion of study treatment
• No medical condition that would preclude study participation
• No confirmed diagnosis of HIV infection, hepatitis B, or hepatitis C

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Study Outline:

Patients are assigned to one of two treatment groups. Patients are assigned to Group 1 until the maximum tolerated dose (MTD) is determined. Once the MTD is determined, additional patients are assigned to Group 2 and treated at the MTD determined in Group 1.

Group 1:

• Patients receive oral PARP inhibitor AZD2281 twice daily on Days 1–4
• Patients also receive gemcitabine hydrochloride IV over 1 hour on Days 3 and 10, and cisplatin IV over 1 hour on Day 3

Group 2:

• Patients receive gemcitabine hydrochloride IV over 1 hour on Days 1 and 8 and cisplatin IV over 1 hour on Day 1 during Course 1 at the MTD determined in Group 1
• For all subsequent courses, patients receive oral PARP inhibitor AZD2281, gemcitabine hydrochloride, and cisplatin as in Group 1 at the MTD determined in Group 1

• In both groups, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
• Patients undergo periodic blood sample collection
• After completion of study treatment, patients are followed for 30 days

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/9/09
Updated: 5/14/09