Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Conditions

• Fallopian Tube Clear Cell Adenocarcinoma
• Fallopian Tube Transitional Cell Carcinoma
• Fallopian Tube Undifferentiated Carcinoma
• Ovarian Clear Cell Adenocarcinoma
• Ovarian Endometrioid Tumor
• Ovarian Seromucinous Carcinoma
• Ovarian Serous Tumor
• Ovarian Transitional Cell Carcinoma
• Ovarian Undifferentiated Carcinoma
• Recurrent Fallopian Tube Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Ovarian Endometrioid Adenocarcinoma
• Recurrent Primary Peritoneal Carcinoma

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Carboplatin — DRUG
  Given IV
• Cediranib Maleate — DRUG
  Given PO
• Computed Tomography — PROCEDURE
  Undergo CT
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• Gemcitabine — DRUG
  Given IV
• Gemcitabine Hydrochloride — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Multigated Acquisition Scan — PROCEDURE
  Undergo MUGA
• Olaparib — DRUG
  Given PO
• Paclitaxel — DRUG
  Given IV
• Pegylated Liposomal Doxorubicin Hydrochloride — DRUG
  Given IV
• Pharmacological Study — OTHER
  Correlative studies
• Quality-of-Life Assessment — OTHER
  Ancillary studies

Study Details

This phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether olaparib or cediranib maleate and olaparib is more effective than standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

Key Dates

Start date

Mar 28, 2016

Status verified

Mar 2026

Primary completion

Feb 23, 2020

Completion

Mar 4, 2027

Study Design

Enrollment

579 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (platinum-based chemotherapy)
  See detailed description.
• Experimental: Arm II (olaparib)
  Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.
• Experimental: Arm III (olaparib, cediranib maleate)
  Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.

Primary Outcome Measure

Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria [ Time Frame: The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months. ]

Locations (337)

Find similar trials in Birmingham, AL

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