AMG 102 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01039207
First received: December 22, 2009
Last updated: April 2, 2011
Last verified: April 2011
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival (PFS) rate at 6 months [ Designated as safety issue: No ]
  • Objective tumor response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
Detailed Description:

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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039207

  Show 30 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
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