Determine MTD, Evaluate Efficacy and Safety of Genexol®-PM Plus Carboplatin With Advanced Ovarian Cancer
This study has been completed.
Sponsor:
Samyang Biopharmaceuticals Corporation
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT00877253
First received: April 3, 2009
Last updated: June 11, 2012
Last verified: June 2012
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Purpose
The purpose of this study is to determine the maximum tolerated dose of Genexol®-PM plus Carboplatin and evaluate the efficacy and safety of Genexol®-PM plus Carboplatin regimen in subjects with advanced ovarian cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: Genexol-PM 220mg/㎡, Carboplatin 5AUC Drug: Genexol-PM 260mg/㎡, Carboplatin 5AUC Drug: Genexol-PM 300mg/㎡, Carboplatin 5AUC |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-label, Multicenter, Phase I Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin as a Firstline Treatment in Subjects With Advanced Ovarian Cancer |
Resource links provided by NLM:
Further study details as provided by Samyang Biopharmaceuticals Corporation:
Primary Outcome Measures:
- Determine the MTD and recommended phase II dose of the combination therapy with Genexol-PM and Carboplatin in subjects with advanced ovarian cancer. [ Time Frame: until either MTD is achieved or maximum planned dose is tested ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Objective Response Rate (Complete Response (CR) + Partial Response (PR)) [ Time Frame: about 1 year (until end of trial) ] [ Designated as safety issue: Yes ]
- Time to Tumor Progression [ Time Frame: about 1 year (until end of trial) ] [ Designated as safety issue: Yes ]
- Overall Survival [ Time Frame: about 1 year (until end of trial) ] [ Designated as safety issue: Yes ]
- Safety profiles [ Time Frame: about 1 year (till end of trial) ] [ Designated as safety issue: Yes ]
| Enrollment: | 18 |
| Study Start Date: | May 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dose Level One |
Drug: Genexol-PM 220mg/㎡, Carboplatin 5AUC
Genexol-PM 220mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.
|
| Experimental: Dose Level Two |
Drug: Genexol-PM 260mg/㎡, Carboplatin 5AUC
Genexol-PM 260mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.
|
| Experimental: Dose Level Three |
Drug: Genexol-PM 300mg/㎡, Carboplatin 5AUC
Genexol-PM 300mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.
|
Detailed Description:
This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol®-PM and Carboplatin and to evaluate the efficacy and safety of Genexol®-PM when administered with Carboplatin in subjects with advanced ovarian cancer after debulking surgery.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Women ≥ 18 years old.
- Signed informed consent before inclusion.
- Subjects who have histologically or cytologically confirmed advanced epithelial ovarian cancer.(FIGO IIIB-IV)
- Subjects who have measurable disease by RECIST after debulking surgery.
- ECOG performance status of 0, 1, or 2.
- Estimated life expectancy of more than 6 months
Subjects who have the clinically acceptable function of blood, kidney and liver at screening visit
- Hb ≥ 10g/dl
- ANC ≥ 1.5×10^9/L
- Platelet Count ≥ 100×10^9/L
- Serum total bilirubin ≤ 1.5×ULN
- Serum AST and ALT ≤ 2.5×ULN
- Serum ALP ≤ 2.5×ULN
- Serum creatinine ≤ 1.5×ULN
Exclusion Criteria:
- Subjects who have received chemotherapy for ovarian cancer other than debulking surgery.
- Subjects who have a history of radiotherapy to pelvis or abdominal cavity
- Subjects who receive immunotherapy or hormonal therapy for ovarian cancer
- Subjects who have other malignancies within the past 5 years
- Subjects who have had a major surgery other than debulking surgery within 2 weeks prior to the screening/baseline visit
- Subjects who have a history of metastasis or currently have a metastasis to the central nervous system(CNS)
- Subjects who have a preexisting sensory or motor neuropathy of grade ≥ 1 based on NCI CTCAE V3.0
Subjects who have serious medical condition
- Uncontrolled or severe cardiovascular disease(Ischemic heart disease, myocardial infarction within the last 6 months, congestive heart failure)
- Uncontrollable infection
- Previous allergic reactions in connection with paclitaxel and carboplatin
- Subjects who participate another clinical trial within the last 4 weeks before inclusion
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877253
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
Investigators
| Principal Investigator: | Soon Beom Kang, MD, PhD | Seoul National University Hospital |
| Principal Investigator: | Yong Man Kim, MD, PhD | Asan Medical Center |
| Principal Investigator: | Byoung Gie Kim, MD, PhD | Samsung Medical Center |
| Principal Investigator: | Young Tae Kim, MD, PhD | Yonsei University Health System Severance Hospital |
More Information
No publications provided
| Responsible Party: | Samyang Biopharmaceuticals Corporation |
| ClinicalTrials.gov Identifier: | NCT00877253 History of Changes |
| Other Study ID Numbers: | GPMOC201 |
| Study First Received: | April 3, 2009 |
| Last Updated: | June 11, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Nonoxynol |
Octoxynol Carboplatin Spermatocidal Agents Antispermatogenic Agents Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Male Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013