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A Phase 2, Non-randomized, Open-label, Multicenter Study of IMC-1121B in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

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Trial Information

A Phase 2, Non-randomized, Open-label, Multicenter Study of IMC-1121B in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma


Current chemotherapies used to treat ovarian cancer patients include doxorubicin, topotecan,
and paclitaxel, to mention a few. Doxorubicin was studied in ovarian cancer patients that
were refractory to paclitaxel and platinum-based chemotherapy agents. Inhibition of
angiogenesis is considered a promising approach to the treatment of cancer. VEGF is an
important regulator of angiogenesis and is likely an important therapeutic target in
persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
VEGF is overexpressed in ovarian tissue and may be the most important single tumor
angiogenic factor. Phase 1 studies currently nearing completion with ramucirumab have
demonstrated safety and tolerability at clinically relevant doses, with preliminary evidence
of clinical efficacy in ovarian cancer patients. Therefore, ImClone Systems plans to conduct
a Phase 2 trial to assess the safety and efficacy of ramucirumab in patients with
platinum-refractory persistent or recurrent epithelial ovarian, fallopian tube, or primary
peritoneal carcinoma.


Inclusion Criteria:



Each patient must meet the following criteria to be enrolled in this study:

1. The patient has recurrent or persistent epithelial ovarian, fallopian tube, or
primary peritoneal carcinoma. Histologic documentation of the original primary tumor
is required via a pathology report

2. The patient has at least one unidimensional-measurable target lesion (≥ 2 cm with
conventional techniques, or ≥ 1 cm by spiral computed tomography [CT] or magnetic
resonance imaging [MRI]), as defined by Response Evaluation Criteria in Solid Tumors
(RECIST).[55] Tumors within a previously irradiated field will be designated as
"nontarget" lesions unless progression is documented or a biopsy is obtained to
confirm persistence at least 90 days following completion of radiation therapy

3. The patient has recovered to Grade ≤ 1 by the National Cancer Institute Common
Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v3.0) from the
effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other
targeted therapies for ovarian cancer, with the exception of alopecia or peripheral
neuropathy (which must have resolved to Grade ≤ 2). Any other prior therapy directed
at the malignant tumor must be discontinued at least three weeks prior to the first
dose of study medication, or hormonal therapy discontinued at least one week prior to
the first dose of study medication. Continuation of hormone replacement therapy is
permitted

4. The patient has completed at least one platinum-based chemotherapeutic regimen for
management of primary disease, and must have at least one of the following: a
platinum-free interval of < 12 months after the final dose of primary platinum-based
therapy, progression during platinum-based therapy, or persistent disease after
platinum-based therapy

5. The patient has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of
0-1 at study entry

6. The patient has adequate hematological functions (absolute neutrophil count [ANC] ≥
1200 cells/uL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000 cells/uL)

7. The patient has adequate hepatic function (bilirubin ≤ 1.5 times the upper limit of
normal [ULN]; aspartate transaminase [AST] and/or alanine transaminase [ALT] ≤ 3.0
times ULN, or ≤ 5.0 times ULN if the transaminase elevation is due to liver
metastases)

8. The patient has adequate renal function (serum creatinine ≤ 1.5 x ULN or creatinine
clearance [measured or calculated] ≥ 60 mL/min)

9. The patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA). If
urine dipstick or routine analysis indicated ≥ 2+ proteinuria, then a 24-hour urine
must be collected and must demonstrate < 1000 mg of protein in 24 hours to allow
participation in the study

10. The patient has adequate coagulation function, as defined by international normalized
ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 1.5 X ULN if not
receiving anticoagulation therapy. Patients on full-dose anticoagulation must be on a
stable dose of oral anticoagulant or low molecular weight heparin, and if on warfarin
must have therapeutic INR and have no active bleeding (defined as within 14 days of
first dose of study medication) or pathological condition that carries a high risk of
bleeding (eg, tumor involving major vessels or known varices)

11. For patients who have received anthracycline therapy, the left ventricular ejection
fraction (LVEF) must be within normal institutional range by a pretreatment
echocardiogram or multigated acquisition (MUGA) scan

12. If sexually active, the patient is post-menopausal, surgically sterile, or using
effective contraception in the opinion of the investigator

13. The patient is ≥ 18 years of age

14. The patient has a life expectancy of ≥ 3 months

15. The patient is able to provide informed written consent and is amenable to compliance
with protocol schedules and testing

Exclusion Criteria:

1. The patient has a concurrent active malignancy, other than adequately treated
nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm. A
patient with previous history of malignancy is eligible provided that she has been
disease-free for > 3 years

2. The patient has received a noncytotoxic regimen (usually called targeted therapy such
as bevacizumab) for recurrent or persistent disease. (Patients may have received a
noncytotoxic regimen as primary treatment.)

3. The patient has received radiotherapy for the treatment of ovarian, fallopian tube,
or primary peritoneal cancer within 3 weeks (21 days) prior to the first dose of
study medication

4. The patients has received 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 last 3 years. (Prior radiation for localized cancer [eg,
of the breast, head and neck, or skin] is permitted, provided that it was completed >
3 years prior to the first dose of study medication, and the patient remains free of
recurrent or metastatic disease.)

5. The patient has received prior chemotherapy for any abdominal or pelvic tumor, other
than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer < 3
years prior to the first dose of study medication. Prior adjuvant chemotherapy for
localized breast cancer is permitted, provided that it was completed >3 years prior
to the first dose of study medication, and that the patient remains free of recurrent
or metastatic disease

6. The patient has undergone major abdominal surgery within 4 weeks (28 days) prior to
first dose of study medication

7. The patient has a suspected impending bowel obstruction, based on clinical or
radiographic criteria

8. The patient has received any hormonal therapy directed at the malignant tumor
discontinued therapy within 1 week (7 days) prior to first dose of study medication

9. The patient has received any other prior therapy directed at the malignant tumor,
including immunologic agents, within 3 weeks (21 days) prior to first dose of study
medication

10. The patient has received previous treatment with ramucirumab

11. The patient has participated in clinical trials of experimental agents within 4 weeks
(28 days) prior to first dose of study medication

12. The patient has a history of uncontrolled hereditary or acquired bleeding or
thrombotic disorders

13. The patient has an ongoing or active infection requiring systemic
antibiotics,symptomatic congestive heart failure, unstable angina pectoris,
symptomatic or poorly controlled cardiac arrhythmia, myocardial infarction < 6
months, Grade ≥ 2 peripheral vascular disease, poorly controlled hypertension despite
standard medical management poorly controlled thrombotic or hemorrhagic disorder,
psychiatric illness or social situations that would limit compliance with study
requirements, or any other serious uncontrolled medical disorders in the opinion of
the investigator

14. The patient has any history of brain metastases or leptomeningeal disease. Screening
for CNS involvement for testing asymptomatic patients is not required

15. The patient has known human immunodeficiency virus infection or acquired
immunodeficiency syndrome-related illness

16. The patient is pregnant (confirmed by serum beta human chorionic gonadotropin [β-HCG]
test) or lactating

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 6 months (PFS-6)

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

E-mail: ClinicalTrials@ ImClone.com

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

13923

NCT ID:

NCT00721162

Start Date:

August 2008

Completion Date:

July 2013

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Carcinoma
  • Ovarian Cancer,
  • Fallopian Tube Cancer
  • Primary Peritoneal Carcinoma
  • Carcinoma
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

ImClone Investigational SiteJacksonville, Florida  32207
ImClone Investigational SiteDecatur, Illinois  62526
ImClone Investigational SiteNew Orleans, Louisiana  70121
ImClone Investigational SiteBaltimore, Maryland  21204
ImClone Investigational SiteMinneapolis, Minnesota  55416
ImClone Investigational SiteDallas, Texas  75230
ImClone Investigational SiteBoston, Massachusetts  02135
ImClone Investigational SiteOklahoma City, Oklahoma  73118
ImClone Investigational SiteSeattle, Washington  98104