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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01650376
Recruitment Status : Unknown
Verified February 2018 by Swedish Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : July 26, 2012
Last Update Posted : March 23, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Swedish Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stage III Ovarian Cancer Stage IV Ovarian Cancer Uterine Cancer Drug: Olaparib Drug: Carboplatin Drug: Paclitaxel Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib With Expansion of Patients at the MTD Study of Olaparib Plus Weekly (Metronomic) Carboplatin and Paclitaxel in Relapsed Ovarian Cancer Patients
Actual Study Start Date : August 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Olaparib plus carboplatin and paclitaxel Drug: Olaparib
Olaparib will be administered orally on Days 1, 2, and 3 of each week until DLT or disease progression. A minimum of 3 patients will be enrolled into each cohort. The anticipated dose escalation sequence of olaparib is 50, 100, 150 and 200 mg, taken twice a day will be used.
Other Names:
  • AZD-2281
  • AZD2281
  • AZD 2281

Drug: Carboplatin
AUC 2 weekly for 3 weeks of a 4 week cycle. For patients who experience a complete response, the carboplatin and paclitaxel will be discontinued and olaparib monotherapy (400 mg, taken twice a day) will continue until disease progression and as long as the investigator feels they are benefiting from the treatment.
Other Names:
  • Paraplatin
  • Paraplatin NovaPlus

Drug: Paclitaxel
60mg/m2 weekly for 3 weeks of a 4 week cycle. For patients who experience a complete response, the carboplatin and paclitaxel will be discontinued and olaparib monotherapy (400 mg, taken twice a day) will continue until disease progression and as long as the investigator feels they are benefiting from the treatment.
Other Names:
  • Taxol
  • Onxol
  • Nov-Onxol
  • Paclitaxel Novaplus




Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicity (DLT) [ Time Frame: 1 cycle (1 cycle = 28 days) ]

Secondary Outcome Measures :
  1. Number of Reported Adverse Events [ Time Frame: Weekly assessments of clinical and laboratory values, and vital sign measurements performed while receiving study treatment. (Anticipated time of 6 months) ]

Other Outcome Measures:
  1. Response to Therapy [ Time Frame: Measured by CT scans performed every 8 weeks while receiving treatment. (Anticipated time of 6 months) ]
  2. Time to Progression [ Time Frame: Measured by CT scans performed every 8 weeks while receiving treatment. (Anticipated time of 6 months) ]
  3. Overall Survival [ Time Frame: Following the last treatment, patient's condition will be monitored every 3 months until death. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650376


Locations
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United States, Washington
Swedish Cancer Institute Edmonds Campus
Edmonds, Washington, United States, 98026
Swedish Cancer Institute Issaquah Campus
Issaquah, Washington, United States, 98029
Pacific Gynecology Specialists
Seattle, Washington, United States, 98104
Swedish Medical Center Cancer Institute
Seattle, Washington, United States, 98104
Swedish Cancer Institute Ballard Campus
Seattle, Washington, United States, 98107
Sponsors and Collaborators
Swedish Medical Center
AstraZeneca
Investigators
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Principal Investigator: Saul Rivkin, MD Swedish Medical Center Cancer Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Swedish Medical Center
ClinicalTrials.gov Identifier: NCT01650376    
Other Study ID Numbers: ISS22810034
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: February 2018
Keywords provided by Swedish Medical Center:
Ovarian Neoplasms
Cancer of the Ovary
Ovarian Cancer
Uterine Neoplasms
Cancer of the Uterus
Uterine Cancer
Olaparib
AZD2281
Carboplatin
Paclitaxel
Relapsed
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Uterine Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Olaparib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators