Trial record 13 of 327 for:    Doxorubicin (liposomal) OR Doxil[TREATMENT] AND HIV [CONDITION]

A Study of Liposomal Doxorubicin With or Without IMC-3G3 in Platinum-refractory or Resistant Advanced Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00913835
First received: June 2, 2009
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to determine if patients with platinum-refractory or platinum-resistant advanced ovarian cancer have a better outcome when treated with IMC-3G3 in combination with Liposomal Doxorubicin then when treated with Liposomal Doxorubicin alone.


Condition Intervention Phase
Ovarian Neoplasms
Biological: IMC-3G3
Drug: liposomal doxorubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase 2 Trial Investigating Liposomal Doxorubicin With or Without Anti-Platelet Derived Growth Factor Receptor-Alpha (PDGFRα) Monoclonal Antibody IMC-3G3 in Patients With Platinum-Refractory or Platinum-Resistant Advanced Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Objective of this study is to evaluate the progression-free survival (PFS) in patients with platinum-refractory or platinum-resistant advanced ovarian cancer when treated with the monoclonal antibody IMC-3G3 in combination with liposomal doxorubicin versus liposomal doxorubicin alone.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Objective Response Rate (ORR) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Median Duration of Response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Summary Listing of Participants Reporting Adverse Events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Serum Anti-IMC-3G3 Antibody Assessment [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Descriptive statistics for safety and efficacy for patients who continue on IMC-3G3 monotherapy following disease progression on liposomal doxorubicin monotherapy. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Area under the curve (AUC) of IMC-3G3 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Maximum Concentration (Cmax) of IMC-3G3 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Half life (t 1/2) of IMC-3G3 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Clearance (Cl) of IMC-3G3 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Apparent Volume of distribution (Vss) of IMC-3G3 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: June 2009
Study Completion Date: February 2014
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMC-3G3 and Liposomal Doxorubicin
IMC-3G3 and Liposomal Doxorubicin
Biological: IMC-3G3
20 mg/kg every 2 weeks (14 days) Treatment will continue until there is evidence of Progressive Disease (PD) or development of unacceptable toxicity
Other Name: LY3012207
Drug: liposomal doxorubicin
40 mg/m2 every 4 weeks (28 days). Treatment will continue until there is evidence of Progressive Disease (PD) or development of unacceptable toxicity
Active Comparator: Liposomal Doxorubicin
Liposomal Doxorubicin Monotherapy until disease progression. Upon disease progression the patient may crossover to IMC-3G3 alone.
Drug: liposomal doxorubicin
40 mg/m2 every 4 weeks (28 days). Treatment will continue until there is evidence of Progressive Disease (PD) or development of unacceptable toxicity

Detailed Description:

The primary objective of this study is to evaluate the progression-free survival (PFS) in patients with platinum-refractory or platinum-resistant advanced ovarian cancer when treated with the monoclonal antibody IMC-3G3 in combination with liposomal doxorubicin versus liposomal doxorubicin alone.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer, or ovarian clear cell carcinoma
  • 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)
  • The patient has a pre-study echocardiogram or multigated acquisition (MUGA) scan with an actual left ventricular ejection fraction (LVEF) ≥ 50%, within 21 days prior to randomization
  • 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. 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
  • 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
  • The patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1 at study entry
  • The patient has the ability to understand and the willingness to sign a written informed consent
  • The patient has adequate hematological functions (absolute neutrophil count [ANC] ≥ 1200 cells/μL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000 cells/μL)
  • 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)
  • 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
  • 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
  • The patient must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5 seconds above ULN. Patients on anticoagulation must be on a stable dose of anticoagulant with a therapeutic INR and no active bleeding within 14 days prior to randomization, or on low molecular weight heparin AND have no pathological condition carrying a high risk of bleeding. Mild elevations of PTT of up to 1.5 × the ULN are acceptable, provided that, in the opinion of the investigator, they are related to ongoing use of coumarins (eg, warfarin)
  • The patient has a pre-study echocardiogram or multigated acquisition (MUGA) scan with an actual left ventricular ejection fraction (LVEF) ≥ 50%, within 21 days prior to randomization
  • women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to randomization and for the duration of study participation

Exclusion Criteria:

  • The patient has brain metastases or leptomeningeal disease
  • The patient received more than one biologic and/or more than one hormonal therapy, administered either concomitantly with platinum-based therapy or separately
  • The patient has a history of treatment with other agents targeting PDGF or PDGFR
  • The patient has an increased level of CA-125 in the absence of concomitant clinical or radiographic progression
  • 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
  • The patient has a suspected impending bowel obstruction (including partial obstruction), based on clinical or radiographic data
  • The patient has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to that of IMC-3G3
  • 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
  • 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
  • The patient is pregnant or lactating
  • 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
  • The patient has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months prior to randomization
  • The patient has participated in clinical trials of experimental agents within 28 days prior to randomization
  • The patient has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
  • The patient has a serious or nonhealing active wound, ulcer, or bone fracture
  • The patient has known human immunodeficiency virus positivity
  • The patient had a major surgical procedure, an open biopsy, or significant traumatic injury within 28 days prior to randomization
  • The patient has received an anthracycline for any indication in the past
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913835

Locations
United States, Illinois
ImClone Investigational Site
Joliet, Illinois, United States, 60435
United States, Indiana
ImClone Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Maryland
ImClone Investigational Site
Baltimore, Maryland, United States, 21237
United States, Massachusetts
ImClone Investigational Site
Boston, Massachusetts, United States, 02114-2621
United States, Michigan
ImClone Investigational Site
Detroit, Michigan, United States, 48202
United States, North Carolina
ImClone Investigational Site
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00913835     History of Changes
Other Study ID Numbers: 13899, 2009-009035-30, CP15-0802, I5B-IE-JGDA
Study First Received: June 2, 2009
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Spain: Comité Ético de Investigación Clínica
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Eli Lilly and Company:
Liposomal Doxorubicin
IMC-3G3
3G3
Platinum resistant
Platinum refractory
Ovary
Neoplasm
PDGFr

Additional relevant MeSH terms:
Doxorubicin
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014