AMG 102 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Recruitment status was Recruiting
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Purpose
RATIONALE: Monoclonal antibodies, such as AMG 102, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase II trial is studying how well AMG 102 works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Malignant Tumor of Peritoneum |
Biological: rilotumumab Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Evaluation of AMG 102 (IND # 107579, NSC #750009) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma |
- Progression-free survival (PFS) rate at 6 months [ Designated as safety issue: No ]
- Objective tumor response rate [ Designated as safety issue: No ]
- Frequency and severity of adverse effects as assessed by the NCI CTCAE [ Designated as safety issue: Yes ]
- Duration of PFS and overall survival (OS) [ Designated as safety issue: No ]
- Association between a panel of biomarkers and measures of response to treatment (including PFS and OS) (translational) [ Designated as safety issue: No ]
- Association between circulating pre- and post-treatment levels of HGF/SF and markers of angiogenesis and measures of response to treatment (including PFS and OS) (translational) [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2009 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To estimate the 6-month progression-free survival (PFS) rate in patients with persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with fully human anti-HGF monoclonal antibody AMG 102.
- To estimate the objective tumor response (complete or partial response) rate in patients treated with this drug.
Secondary
- To determine the frequency and severity of adverse events associated with this drug in these patients.
- To determine the duration of PFS and overall survival of patients treated with this drug.
Tertiary
- To explore the association between a panel of biomarkers (as assayed by IHC and mutation analysis) and measures of response to treatment and clinical outcome in archived tumor tissue. (Translational)
- To evaluate circulating pre- and post-treatment levels of hepatocyte growth factor/scatter factor and markers of angiogenesis, and their association with response to treatment and clinical outcome. (Translational)
OUTLINE: This is a multicenter study.
Patients receive fully human anti-HGF monoclonal antibody AMG 102 IV over 30-60 minutes on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
Tumor tissue and blood samples may be collected periodically for further laboratory analysis.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed recurrent or persistent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma
- Histologic confirmation of the original primary tumor via pathology report required
Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 10 mm by CT scan, MRI, or caliper measurement by clinical exam OR ≥ 20 mm by chest x-ray
- Lymph nodes must be ≥ 15 mm in short axis when measured by CT scan or MRI
Has ≥ 1 "target lesion" to be used to assess response, as defined by RECIST criteria
- Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days following completion of radiotherapy
Must have received 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
- Initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, non-cytotoxic agents, or extended therapy administered after surgical or non-surgical assessment
- Must have a platinum-free interval of < 12 months, progressed during platinum-based therapy, or have persistent disease after platinum-based therapy
- One additional cytotoxic regimen for management of recurrent or persistent disease allowed
- Ineligible for a higher priority GOG protocol, if one exists (e.g., any active GOG phase III protocol for the same patient population)
PATIENT CHARACTERISTICS:
- GOG performance status (PS) 0-2 (for patients who received 1 prior regimen)
- GOG PS 0-1 (for patients who received 2 prior regimens)
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- SGOT ≤ 3.0 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- PTT ≤ 1.5 times ULN
- INR ≤ 1.5 times ULN
- Proteinuria ≤ 1+ by urinalysis OR ≤ 1 g/24 hrs by 24-hour urine collection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No neuropathy (sensory or motor) > grade 1
- No peripheral edema or lymphedema > grade 2
- No active bleeding diathesis
No thromboembolic or ischemic event within the past 12 months, including any of the following:
- Deep venous thrombosis
- Pulmonary embolism
- Transient ischemic attack
- Cerebral infarction
- Myocardial infarction
- No serious or non-healing wound
- No known HIV or hepatitis C positivity or chronic or active hepatitis B
No active infection requiring antibiotics
- Uncomplicated urinary tract infection allowed
- No other concurrent serious infection or nonmalignant medical illness that is uncontrolled or whose control may be jeopardized by study treatment
- No psychiatric condition or other condition that would preclude giving informed consent or meeting study requirements
No history of primary endometrial cancer unless all of the following criteria are met:
- No greater than stage IB disease
- No more than superficial myometrial invasion
- No vascular or lymphatic invasion
- No poorly differentiated subtypes, including papillary serious, clear cell, or other FIGO grade 3 lesions
- No other invasive malignancies within the past 3 years except for nonmelanoma skin cancer or localized cancer of the breast, head and neck, or skin
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior surgery, radiotherapy, or chemotherapy
- No prior cancer treatment that would contraindicate study treatment
- No prior fully human anti-HGF monoclonal antibody AMG 102 or other HGF/c-met pathway inhibitors
No prior non-cytotoxic therapy for management of recurrent or persistent disease
- Prior biologic (non-cytotoxic) therapy as part of primary treatment regimen allowed
No prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the past 3 years
- Prior radiotherapy for localized cancer of the breast, head and neck, or skin is allowed provided it was completed > 3 years ago and the patient remains free of recurrent or metastatic disease
No prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the past 3 years
- Prior adjuvant chemotherapy for localized breast cancer allowed provided it was completed > 3 years ago and the patient remains free of recurrent or metastatic disease
More than 30 days since prior surgery (14 days for minor surgical procedures)
- Central venous catheter placement allowed at any time point before study enrollment provided the patient has recovered and any surgical wound has healed
- At least 1 week since prior hormonal therapy directed at the malignant tumor
- At least 3 weeks since any other prior therapy directed at the malignant tumor, including immunologic agents
More than 7 days since prior and no concurrent therapeutic anti-coagulation therapy with warfarin, heparin, or low molecular weight heparin
- Low-dose warfarin (≤ 2 mg orally daily) for prophylaxis against central venous catheter thrombosis allowed
Contacts and Locations
Show 30 Study Locations| Principal Investigator: | Lainie Martin, MD | Fox Chase Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01039207 History of Changes |
| Other Study ID Numbers: | CDR0000662115, GOG-0170P |
| Study First Received: | December 22, 2009 |
| Last Updated: | April 2, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
fallopian tube cancer peritoneal cavity cancer recurrent ovarian epithelial cancer |
Additional relevant MeSH terms:
|
Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 23, 2013