Phase Ib Study of Olaparib Plus Weekly Carboplatin and Paclitaxel in Relapsed Ovarian Cancer
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| ClinicalTrials.gov Identifier: NCT01650376 |
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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
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Sponsor:
Swedish Medical Center
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Swedish Medical Center
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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 |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ovarian cancer
MedlinePlus related topics:
Ovarian Cancer
| 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:
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:
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:
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Primary Outcome Measures :
- Incidence of Dose Limiting Toxicity (DLT) [ Time Frame: 1 cycle (1 cycle = 28 days) ]
Secondary Outcome Measures :
- 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:
- Response to Therapy [ Time Frame: Measured by CT scans performed every 8 weeks while receiving treatment. (Anticipated time of 6 months) ]
- Time to Progression [ Time Frame: Measured by CT scans performed every 8 weeks while receiving treatment. (Anticipated time of 6 months) ]
- Overall Survival [ Time Frame: Following the last treatment, patient's condition will be monitored every 3 months until death. ]
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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:
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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
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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
| 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
| Principal Investigator: | Saul Rivkin, MD | Swedish Medical Center Cancer Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
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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 |