Phase Ib Study of Olaparib Plus Weekly Carboplatin and Paclitaxel in Relapsed Ovarian Cancer

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Stage III Ovarian Cancer, Stage IV Ovarian Cancer, Uterine Cancer

In brief

The purpose of this study is to determine the maximum tolerated dose (MTD) of the investigational agent, olaparib, to give in combination with carboplatin and paclitaxel in patients with relapsed ovarian cancer or uterine cancer. Furthermore, the investigators intend to study the safety and tolerability of the study treatment, response to treatment, time to disease progression, and overall survival.

Key facts

Study ID

NCT01650376

Run by

Swedish Medical Center

People needed

52

Starts

2012-08-01

Expected to finish

2019-12-01

Last updated by the study team

2018-03-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Advanced (stage III or IV), histologically or cytologically documented ovarian cancer or serious uterine cancer patients who relapsed after primary therapy with a platinum and a taxane. This includes:
• Platinum sensitive: relapsed at least 6 months following platinum treatment
• Platinum refractory: the cancer grew while on platinum treatment
• Platinum resistant: recurrence within 6 months of platinum treatment
• Must have failed first line treatment
• ECOG performance status 0-2
• Must be able to swallow and retain oral medication
• Life expectancy greater than 16 weeks
• Must have normal organ and bone marrow function defined as follows:
• Hemoglobin ≥ 9.0 g/dL
• Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
• White blood cells (WBC) > 3 x 10\^9/L
• Platelet count ≥ 100 10\^9/L
• Total bilirubin ≤ 1.5 x institutional upper limit of normal
• AST (SGOT)/ALT (SGPT) ≤ x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5 ULN
• Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)

You may not qualify if…

• Any previous treatment with a PARP inhibitor, including olaparib
• Any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or longer period depending on the defined characteristics of the agents used)
• Currently receiving the following classes of inhibitors of CYP3A4: azole antifungals, macrolide antibiotics, and protease inhibitors
• Second primary cancer except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
• Symptomatic uncontrolled brain metastases
• Major surgery within 2 weeks of starting study treatment
• Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
• Known active hepatic disease (i.e. Hepatitis B or C)
• Uncontrolled seizures
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin or paclitaxel

Where it is running

• Swedish Cancer Institute Edmonds Campus — Edmonds, Washington, United States
• Swedish Cancer Institute Issaquah Campus — Issaquah, Washington, United States
• Pacific Gynecology Specialists — Seattle, Washington, United States
• Swedish Medical Center Cancer Institute — Seattle, Washington, United States
• Swedish Cancer Institute Ballard Campus — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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