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Ovarian CancerPhase 3PROCEEDNCT01170650

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

A Phase 3 study testing EC145, Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®) and EC20 in people with Ovarian Cancer, run by Endocyte.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
EC145, Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®) and EC20
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
441 participants
Where
No sites listed yet
Study dates
22 Apr 2011to 8 Sep 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 regimens.
  • 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:
  • Bone Marrow Reserve:
  • Absolute neutrophil count (ANC) ≥ 1.5x10^9/L prior to treatment. Participants on maintenance doses of granulocyte colony stimulating factor (G-CSF) are eligible.
  • Platelets ≥ 100x10^9/L
  • Hemoglobin ≥ 9 g/dL
  • Use of supportive care measures (eg, use of white blood cell [WBC] growth factors, antiemetics, epoetin) should follow the ASCO guidelines as listed at www.asco.org. 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.
  • Hepatic: Total bilirubin level < 1.5 x ULN and ALT, AST, GGT, and alkaline phosphatase levels < 2.5 x ULN.
  • 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
  • Cardiac: Left ventricular ejection fraction (LVEF) equal to or greater than the institutional lower limit of normal.

Who cannot join

  • 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.
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  • 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.

About this study

Official title: A Randomized Double-Blind Phase 3 Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®) in Combination Versus PLD in Participants With Platinum-Resistant Ovarian Cancer

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.

Read the detailed description

This is a Phase 3 clinical trial to evaluate the efficacy and safety of the combination of EC145 and pegylated liposomal doxorubicin (PLD; available in the United States as Doxil® and outside the United States as Caelyx®) compared to PLD and placebo. Enrollment of 640 patients including approximately 500 that are folate receptor positive is planned.

EC145 is a drug that is specifically designed to enter cancer cells via the folate vitamin receptor (FR) that is not generally found on normal cells. Experimental evidence shows that this target receptor is expressed on virtually all ovarian cancers. Early clinical evidence in a small number of Phase I participants, in a subset of participants in a completed single-arm Phase II study, and interim data from an ongoing randomized Phase 2 study (PRECEDENT) suggests that EC145 may have antitumor effect in women with platinum-resistant ovarian cancer and that EC145 alone and in combination with PLD is generally well-tolerated. This evidence suggests that EC145 may be useful as chemotherapy against platinum-resistant ovarian cancer.

All participants will undergo imaging with the FR-targeting investigational diagnostic agent EC20 during the screening period to assess binding of the imaging agent EC20 to tumors. This non-invasive procedure will provide additional information on the utility of using EC20 imaging to identify subjects with the FR molecular "target" prior to treatment with EC145 therapy.

Conditions
Ovarian Cancer
Being tested
EC145, Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®), placebo, EC20
Keywords
cancer, ovarian, platinum-resistant, Phase III, EC145, EC20
Medical subject headings
Ovarian Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EC145Drug

    IV bolus on days 1,3,5 and 15,17,19 of a 4-week cycle

  • Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®)Drug

    Also called Doxil, Caelyx

    50 mg/m2 (calculated on the basis of ideal body weight) every 4 weeks. Dose reductions permitted for toxicity.

  • placeboDrug

    IV bolus on days 1,3,5 and 15,17,19 of a 4-week cycle

  • EC20Drug

    During the screening period participants will receive a single intravenous administration of EC20 prior to SPECT imaging

Study groups in NCT01170650
Study groupRoleWhat they receive
Arm AExperimentalEC145 + Pegylated Liposomal Doxorubicin (PLD)
Receives: Drug: EC145; Drug: Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®); Drug: EC20
Arm BActive comparatorplacebo + Pegylated Liposomal Doxorubicin (PLD)
Receives: Drug: Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®); Drug: placebo; Drug: EC20

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival based on investigator assessment using RECIST v1.1.

    Progression is assessed at 6 week intervals through Week 24 and at 8 week intervals thereafter.

    Measured: up to 26 months

Secondary outcomes (2)

  1. Compare overall survival of participants between treatment arms.

    OS analysis will occur when 384 deaths have occurred.

    Measured: Approximately 20 months after last patient randomized

  2. Incidence of Adverse Events, Serious Adverse Events, and Deaths.

    Adverse events (as a measure of safety and tolerability) will be assessed at each study visit.

    Measured: up to 26 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2010 (estimated)
  2. Study start22 Apr 2011
  3. Primary completion31 May 2015
  4. Study completion8 Sep 2015

Why it stopped: DSMB decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
441 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01170650
Sponsor's protocol ID
8109-002
Other IDs
EC-FV-06
Acronym
PROCEED
Status last verified
Sep 2021
First submitted
7 Jul 2010
Last updated
30 Sep 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EC145, Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®) and EC20 in people with Ovarian Cancer, run by Endocyte.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: DSMB decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival based on investigator assessment using RECIST v1.1. (time frame: up to 26 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01170650.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.

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