Randomized Phase 2 Trial Investigating Liposomal Doxorubicin With or Without Anti Platelet Derived Growth Factor Receptor-Alpha (PDGFRa) Monoclonal Antibody IMC-3G3 in Patients With Platinum-Refractory or Platinum-Resistant Advanced Ovarian Cancer.
- Conditions
- Platinium-refractory or Platinium-resistant Advanced Ovarian CancerMedDRA version: 12.0 Level: PT Classification code 10033128 Term: Ovarian cancer
- Registration Number
- EUCTR2009-009035-30-GB
- Lead Sponsor
- ImClone LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 125
Each patient must meet the following criteria to be enrolled in this study:
1. The patient has histologically or cytologically confirmed epithelial ovarian cancer,
primary peritoneal carcinoma, fallopian tube cancer, or ovarian clear cell carcinoma.
2. The patient has completed at least one and up to three platinum-containing regimens (involving cisplatin, carboplatin, or another organoplatinum) for the management of this condition. Treatment may have included intraperitoneal therapy, high-dose therapy, consolidation or extended therapy administered after surgical or
nonsurgical assessment.
3. The patient must have at least one of the following: a platinum-free interval of
= 12 months after the final dose of primary or subsequent platinum-based therapy
(platinum-resistant), progression during primary or subsequent platinum-based therapy (platinum-refractory), or persistent radiographic disease after primary or subsequent platinum-based therapy (platinum-refractory).
4. The patient has at least one unidimensionally measurable target lesion (= 20 mm with conventional techniques, or = 10 mm by spiral computed tomography [CT] or magnetic resonance imaging [MRI]), as defined by Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST v 1.0) guidelines.
5. The patient is of age = 18 years.
6. 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). The exceptions for such effects are
allowed lab values of = Grade 2 specified elsewhere in these inclusion criteria. (For
example, criterion # 9 states that a patient with hemoglobin = 9.5 g/dL is considered
eligible, even though NCI-CTCAE v 3.0 defines this value as Grade 2 decreased
hemoglobin.
7. The patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of = 1 at study entry.
8. The patient has the ability to understand and the willingness to sign a written informed consent.
9. The patient has adequate hematological functions (absolute neutrophil count [ANC] = 1200 cells/µL, hemoglobin = 9 g/dL, and platelets = 100,000 cells/µL).
10. The patient has adequate hepatic function as defined by total bilirubin = 1.5 × the upper limit of normal (ULN), and aspartate transaminase (AST) and alanine transaminase (ALT) = 3 × the ULN (or = 5 × the ULN in the presence of known liver metastases).
11. The patient has adequate renal function as defined by serum creatinine = 1.5 × the institutional ULN. If creatinine is above the ULN, the patient’s creatinine clearance is = 60 mL/min.
12. The patient has urinary protein = 1+ on dipstick or routine urinalysis; if urine dipstick or routine analysis is = 2+, a 24-hour urine for protein must demonstrate
< 1000 mg of protein to allow participation.
13. The patient must have adequate coagulation function as defi
Patients who meet any of the following criteria will be excluded from the study:
1. The patient has brain metastases or leptomeningeal disease.
2. The patient received more than one biologic and/or more than one hormonal therapy, administered either concomitantly with platinum-based therapy or separately.
3. The patient has a history of treatment with other agents targeting PDGF or PDGFR.
4. The patient has an increased level of CA-125 in the absence of concomitant clinical or radiographic progression.
5. The patient has received radiotherapy, chemotherapy, or biologic therapy directed at the malignant tumor within 3 weeks prior to randomization, or hormonal therapy directed at the malignant tumor within 1 week prior to randomization. Continuation of hormone replacement therapy is permitted.
6. The patient has a suspected impending bowel obstruction (including partial obstruction), based on clinical or radiographic data.
7. The patient has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to that of IMC-3G3.
8. The patient has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study
requirements.
9. The patient has a history of another primary cancer, with the exception of:
a) curatively resected nonmelanomatous skin cancer;
b) curatively treated cervical carcinoma in-situ; or
c) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 3 years prior to randomization.
10. The patient is pregnant or lactating.
11. The patient has ongoing side effects = Grade 2 due to agents administered more than 28 days prior to randomization. The exceptions for such effects are allowed lab values and toxicities of = Grade 2, specified in the inclusion criteria. (For example, inclusion criterion # 9 states that a patient with hemoglobin = 9.5 g/dL is considered eligible, even though NCI-CTCAE v 3.0 defines this value as Grade 2 decreased hemoglobin).
12. The patient has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months prior to randomization.
13. The patient has participated in clinical trials of experimental agents within 28 days prior to randomization.
14. The patient has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders.
15. The patient has a serious or nonhealing active wound, ulcer, or bone fracture.
16. The patient has known human immunodeficiency virus positivity.
17. The patient had a major surgical procedure, an open biopsy, or significant traumatic injury 28 days prior to randomization.
18. The patient has received an anthracycline for any indication in the past.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method