Study of Adding AMG 479 to First Line Chemotherapy in Patients With Optimally Debulked Epithelial Ovarian Cancer
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| ClinicalTrials.gov Identifier: NCT00718523 |
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Recruitment Status :
Terminated
(The steering committee of the TRIO014 study has taken the decision to stop the TRIO014 trial.)
First Posted : July 18, 2008
Results First Posted : January 12, 2016
Last Update Posted : January 12, 2016
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Sponsor:
Translational Research in Oncology
Information provided by (Responsible Party):
Translational Research in Oncology
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Brief Summary:
This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ovarian Neoplasms | Drug: AMG 479 Drug: AMG 479 Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 170 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind, Placebo Controlled, Multi-center, Phase II Study of Adding AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) to First Line Chemotherapy in Patients With Optimally Debulked ( < 1 cm ) Epithelial Ovarian Cancer |
| Study Start Date : | January 2009 |
| Actual Primary Completion Date : | September 2013 |
| Actual Study Completion Date : | November 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ovarian cancer
MedlinePlus related topics:
Ovarian Cancer
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: A
Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.
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Drug: AMG 479 Placebo
Matching placebo administered Day 1 of each 21 day cycle. |
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Experimental: B
AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.
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Drug: AMG 479
Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle |
Primary Outcome Measures :
- Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death. [ Time Frame: Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle ]
A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:
- Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR
- Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR
- CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart
Secondary Outcome Measures :
- Time To Progression (TTP): Interval From the Date of Randomization to the Date of Disease Progression [ Time Frame: Radiological tumor assessment: every 12 (+/- 1) weeks for 3 years after randomization + CA125: day 1 of each cycle ]
A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:
- Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR
- Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR
- CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart
- Overall Survival (OS) [ Time Frame: Day 1 of each cycle up to 4 years after randomization ]Interval between the date from randomization to death from any cause whichever came first.
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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:
- Histologically-confirmed optimally debulked (< 1 cm) FIGO stage III or stage IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
- Patients should have undergone surgical debulking, by a surgeon experienced in the management of ovarian cancer, with the aim of maximal surgical cytoreduction. All patients must be optimally debulked as defined as having no residual tumor of greater than 1 cm in the post surgical setting.
- Patients with stage IV disease will be eligible if a positive pleural cytology is the only extra peritoneal disease.
- Paraffin block (or 10 - 20 unstained slides) and fresh frozen surgical/biopsy specimens of the primary tumor are required at baseline.
- No prior systemic treatment in the primary disease treatment setting.
- Female ≥ 18 years of age or legal age.
- ECOG performance status ≤ 2.
- Adequate organ and bone marrow function
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Non diabetic patients or Type 1 or 2 Diabetic Patients:
• Diabetes must be controlled with HgbA1c < 8% and fasting blood glucose level <160 mg/dL.
- Patient must be willing and able to comply with scheduled visits, and all study procedures.
- Informed consent obtained.
- Patients should be able to commence systemic therapy within 6 weeks of cytoreductive surgery.
- Life expectancy > 12 weeks.
- Adequate coagulation parameters (within 14 days prior to randomization), International Normalized Ratio (INR) ≤1.5; Activated Prothrombin Time (APTT) ≤ 1.5 x ULN
Exclusion Criteria:
- Non-epithelial ovarian cancer, including malignant mixed Mullerian tumors.
- Borderline tumors (tumors of low malignant potential).
- Planned intraperitoneal cytotoxic chemotherapy.
- Prior systemic anticancer therapy for ovarian cancer.
- Any previous radiotherapy to the abdomen or pelvis.
- Patients with synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless ALL of the following criteria for describing the endometrial carcinoma are met: Stage ≤ Ib, no more than superficial myometrial invasion, no lymphovascular invasion, not poorly differentiated (i.e., not Grade 3 or papillary serous or clear cell).
- Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri or curatively treated DCIS/LCIS, or non-melanoma or in situ melanoma skin cancer.
- Prior treatment with a humanized monoclonal antibody anticancer therapeutic.
- Prior treatment with investigational treatment targeted to IGF axis including, but not limited to, CP 751,871, IM-A12, RO4858696.
- Previous exposure to AMG 479.
- Anticipation of a need for a major surgical procedure or radiation therapy during the study.
- History of hypersensitivity to recombinant proteins.
- Treatment with radiotherapy, surgery, or an investigational agent within 4 weeks of randomization.
- Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, grade > 2 peripheral neuropathy, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
- History of brain metastases, spinal cord compression, or carcinomatous meningitis.
- Patient of child-bearing potential is pregnant (eg, positive human chorionic gonadotropin test) or is breast feeding.
- Patient of child-bearing potential is not willing to use adequate contraceptive precautions.
- Known active infection, or on antiretroviral therapy for HIV disease.
- Known positive test for chronic hepatitis B or C infection.
- Any other underlying physical or mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
- Refusal or inability to give informed consent to participate in the study.
- Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
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): NCT00718523
Locations
Show 55 study locations
Sponsors and Collaborators
Translational Research in Oncology
Investigators
| Study Chair: | Gottfried E Konecny, MD | University of California, Los Angeles |
| Responsible Party: | Translational Research in Oncology |
| ClinicalTrials.gov Identifier: | NCT00718523 |
| Other Study ID Numbers: |
TRIO 014 |
| First Posted: | July 18, 2008 Key Record Dates |
| Results First Posted: | January 12, 2016 |
| Last Update Posted: | January 12, 2016 |
| Last Verified: | December 2015 |
Additional relevant MeSH terms:
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial 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 Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |