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Ovarian CarcinomaPhase 2PGANCT01936974

(PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma

A Phase 2 study testing Gemcitabine, Bevacizumab and Carboplatin in people with Ovarian Carcinoma and Fallopian Tube Carcinoma, run by Western Regional Medical Center at 1 site in United States.

Terminated

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

Official record
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Trial summary

To evaluate progression-free survival with two chemotherapy regimens on platinum-resistant/refractory ovarian and peritoneal carcinoma Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Gemcitabine, Bevacizumab and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
Sep 2013to Aug 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients ≥ 18 years of age with histologically confirmed, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
  • Disease progression during or within 6 months of previous platinum-based chemotherapy including the following 4 categories:
  • Primary platinum-refractory: Previously untreated patients who do not achieve at least a partial response to platinum-based chemotherapy
  • Primary platinum-resistant: Previously untreated patients who have achieved at least a partial response to platinum-based chemotherapy but experience a relapse within a period of 6 months of its conclusion
  • Secondary platinum-refractory: Previously treated patients have a relapse 6 months after the conclusion of chemotherapy, but fail to achieve at least a partial response
  • Secondary platinum-resistant: Previously treated patients have a relapse 6 months after the conclusion of chemotherapy, achieve at least a partial response with platinum-based therapy as 2nd-line therapy, but experience relapse within 6 months
Show all 11Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2 and a life expectancy >3 months.
  • Absolute neutrophil count > 1500 mm^3, platelet count ≥ 100×10^9 L, hemoglobin ≥ 8.5 g/dL
  • Serum creatinine ≤1.5 times the upper limit of the normal range, total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range
  • No remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the Principal Investigator
  • At least three (3) weeks from prior chemotherapy

Who cannot join

  • Inadequate renal function with a calculated creatinine clearance less than 51 mL/min
  • Uncontrolled cardiac disease, congestive heart failure, angina, or hypertension
  • Myocardial infarction or unstable angina within 2 months of treatment
  • Known human immunodeficiency virus (HIV) infection or chronic active Hepatitis B or C (patients are NOT required to be tested for the presence of such viruses prior to therapy on this protocol)
  • Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks, pulmonary embolism within the past 6 months
  • Bleeding diathesis or significant coagulopathy
Show all 18Show fewer
  • Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug
  • Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug
  • History of fistula, GI perforation, or intrabdominal abscess
  • Serious non-healing wound, ulcer, or bone fracture
  • clinical signs or symptoms of GI obstruction and/or requirement for parenteral hydration or nutrition
  • Known CNS disease except for treated brain metastasis
  • Known platinum drug allergy
  • Prior treatment with Platinum + Gemcitabine + Avastin, Gemcitabine + Avastin or Gemcitabine alone
  • Prior treatment with more than three (3) lines of chemotherapy including adjuvant chemotherapy
  • Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug
  • Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
  • Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Western Regional Medical Center

    Goodyear, Arizona, 85338

Other trials in United States

About this study

Official title: Platinum-Gemcitabine-Avastin (PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma

To evaluate progression-free survival with two chemotherapy regimens on platinum-resistant/refractory ovarian and peritoneal carcinoma

Read the detailed description

This study will evaluate progression-free survival (PFS)for the regimen of gemcitabine and bevacizumab with or without a platinum agent on platinum-resistant/refractory ovarian and peritoneal carcinoma

Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

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

  • GemcitabineDrug

    Also called Gemzar

    Patient to receive gemzar

  • BevacizumabDrug

    Also called Avastin

    Patient to receive avastin

  • CarboplatinDrug

    Also called Paraplatin

    Patient to receive carboplatin

  • CisplatinDrug

    Also called Platinol

    Patient to receive cisplatin

  • OxaliplatinDrug

    Also called Eloxatin

    Patient to receive Oxaliplatin

Study groups in NCT01936974
Study groupRoleWhat they receive
Platinum, Gemcitabine and BevacizumabExperimentalPlatinum: 1. Carboplatin* on day 1 *If a patient is allergic to carboplatin, then give 2. Cisplatin** on day 1 **If a patient is allergic to cisplatin and carboplatin, then give 3. Oxaliplatin on day 1 Gemcitabine on day 1 only Bevacizumab on day 1
Receives: Drug: Gemcitabine; Drug: Bevacizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Oxaliplatin
Gemcitabine and BevacizumabActive comparatorGemcitabine on days 1 and 8 Bevacizumab on day 1
Receives: Drug: Gemcitabine; Drug: Bevacizumab

What is being measured

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

  1. Progression-free Survival

    Evaluate progression-free survival between the two regimens.

    Measured: One Year

Timeline

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

  1. First posted6 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionAug 2015
  4. Study completionAug 2015

Why it stopped: PI 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01936974
Sponsor's protocol ID
13-27
Acronym
PGA
Status last verified
Jan 2018
First submitted
3 Sep 2013
Last updated
20 Feb 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, Bevacizumab and Carboplatin in people with Ovarian Carcinoma and Fallopian Tube Carcinoma, run by Western Regional Medical Center at 1 site in United States.

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 11 inclusion and 18 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 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (time frame: One Year). 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 NCT01936974.

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 20 Feb 2018.

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