Trial Search Results

Study for Women With Platinum Resistant Ovarian Cancer Evaluating EC145 in Combination With Doxil® (PROCEED)

The purpose of this study is to compare progression-free survival (PFS) (based upon investigator assessment using RECIST v1.1) in participants with platinum-resistant ovarian cancer who receive combination therapy with EC145 and pegylated liposomal doxorubicin (EC145+PLD) with that in participants who receive PLD and placebo.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:



  • Drug: EC145
  • Drug: Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®)
  • Drug: placebo
  • Drug: EC20


Phase 3


Inclusion Criteria:

   - Participants must sign an approved informed consent form (ICF).

   - Participants must be ≥ 18 years of age.

   - Participants must have pathology-confirmed epithelial ovarian, fallopian tube, or
   primary peritoneal carcinoma.

   - Participants must have primary or secondary platinum-resistant ovarian cancer.

   - Participants must have at least a single (RECIST v1.1-defined) measurable lesion.

   - For the purpose of obtaining a RECIST v1.1 baseline scan, participants must have a
   radiological evaluation conducted no more than 28 days prior to beginning study
   therapy (PLD). NOTE: For participants with a history of CNS metastasis, baseline
   radiological imaging must include an evaluation of the head.

   - Participants must have had prior debulking surgery.

   - Participants must have received prior platinum-based chemotherapy for management of
   primary disease but must not have received more than 2 prior systemic cytotoxic

   - Participants are allowed to have received, but are not required to have received, one
   additional non-cytotoxic antitumor agent (eg, biologic or cytostatic) for the
   management of ovarian cancer.

   - Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status
   of 0 to 1.

   - Participants must have recovered (to baseline/stabilization) from prior cytotoxic
   therapy-associated acute toxicities.

   - Participants must have adequate organ function including:

      1. Bone Marrow Reserve:

         1. Absolute neutrophil count (ANC) ≥ 1.5x10^9/L prior to treatment.
         Participants on maintenance doses of granulocyte colony stimulating factor
         (G-CSF) are eligible.

         2. Platelets ≥ 100x10^9/L

         3. Hemoglobin ≥ 9 g/dL

         4. Use of supportive care measures (eg, use of white blood cell [WBC] growth
         factors, antiemetics, epoetin) should follow the ASCO guidelines as listed
         at Participants should receive full supportive care, including
         transfusion of blood as mandated by clinical need; however, transfusions
         administered for the sole purpose of meeting the study inclusion criteria
         between the time informed consent is signed and first dose of
         EC145/placebo/PLD is administered are not allowed.

      2. Hepatic: Total bilirubin level < 1.5 x ULN and ALT, AST, GGT, and alkaline
      phosphatase levels < 2.5 x ULN.

      3. Renal: Serum creatinine level ≤ 1.5 x ULN or for participants with serum
      creatinine levels above 1.5 x ULN, creatinine clearance ≥ 50 mL/min/1.73m^2

      4. Cardiac: Left ventricular ejection fraction (LVEF) equal to or greater than the
      institutional lower limit of normal.

Exclusion Criteria:

   - Patients refractory to primary platinum therapy where "refactory" is defined as
   disease progression within 6 months of first dose of initial platinum-based therapy.

   - Diagnosis of "tumor of low-malignant potential".

   - Prior exposure to PLD or anthracycline therapy.

   - Prior exposure to FR-targeted therapy (eg, EC145, EC0225, EC0489, farletuzumab).

   - Prior therapy with vinorelbine (Navelbine®) or vinca-containing compounds.

   - Prior abdominal or pelvic radiation therapy or radiation therapy to > 10% of the bone
   marrow at any time in the past or prior radiation therapy within the past 3 years to
   the breast/sternum, dermal lesions, head or neck.

   - Recent (i.e., ≤ 6 weeks) history of abdominal surgery or peritonitis

   - Serious comorbidities (as determined by the investigator) such as, but not limited to,
   active congestive heart failure or recent myocardial infarction. Patients who require
   antifolate therapy for the management of comorbid conditions (e.g., rheumatoid
   arthritis) will be excluded from the trial.

   - Pregnant or nursing.

   - Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma
   in situ).

   - Symptomatic central nervous system (CNS) metastasis.

   - Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy
   that is considered to be investigational (i.e., used for non-approved indications(s)
   and in the context of a research investigation). Use of low dose corticosteroid
   therapy (e.g., for nausea prophylaxis) is acceptable; however, concomitant tamoxifen
   therapy is not. Supportive care measures are allowed.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting