Phase Ib Study of Olaparib Plus Weekly Carboplatin and Paclitaxel in Relapsed Ovarian Cancer
This study is currently recruiting participants.
Verified August 2012 by Swedish Medical Center
Sponsor:
Swedish Medical Center
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT01650376
First received: July 18, 2012
Last updated: August 10, 2012
Last verified: August 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Stage III Ovarian Cancer Stage IV Ovarian Cancer Uterine Cancer |
Drug: Olaparib Drug: Carboplatin Drug: Paclitaxel |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Swedish Medical Center:
Primary Outcome Measures:
- Incidence of Dose Limiting Toxicity (DLT) [ Time Frame: 1 cycle (1 cycle = 28 days) ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: Yes ]
Other Outcome Measures:
- Response to Therapy [ Time Frame: Measured by CT scans performed every 8 weeks while receiving treatment. (Anticipated time of 6 months) ] [ Designated as safety issue: Yes ]
- Time to Progression [ Time Frame: Measured by CT scans performed every 8 weeks while receiving treatment. (Anticipated time of 6 months) ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: Following the last treatment, patient's condition will be monitored every 3 months until death. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 52 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650376
Contacts
| Contact: Barry Boatman, RN, MA, OCN | (206) 215-3086 | CancerResearch@Swedish.org |
Locations
| United States, Washington | |
| Swedish Medical Center Cancer Institute | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Barry Boatman, RN, MA, OCN 206-215-3086 CancerResearch@Swedish.org | |
| Principal Investigator: Saul Rivkin, MD | |
Sponsors and Collaborators
Swedish Medical Center
AstraZeneca
Investigators
| Principal Investigator: | Saul Rivkin, MD | Swedish Medical Center Cancer Institute |
More Information
No publications provided
| Responsible Party: | Swedish Medical Center |
| ClinicalTrials.gov Identifier: | NCT01650376 History of Changes |
| Other Study ID Numbers: | ISS22810034 |
| Study First Received: | July 18, 2012 |
| Last Updated: | August 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Swedish Medical Center:
|
Uterine Neoplasms Cancer of the Uterus Uterine Cancer Ovarian Neoplasms Cancer of the Ovary Ovarian Cancer |
Olaparib AZD2281 Carboplatin Paclitaxel Relapsed |
Additional relevant MeSH terms:
|
Uterine Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Endocrine System Diseases Gonadal Disorders Uterine Diseases Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Genital Neoplasms, Female |
Urogenital Neoplasms Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013