Clinical Trials /

Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Ovarian Cancer

NCT03632798

Description:

The purpose of this randomized clinical study is to confirm the utility of chemosensitivity (ChemoID) tumor testing on cancer stem cells as a predictor of clinical response in recurrent epithelial ovarian cancer (EOC), fallopian tube, or primary peritoneal cancer, regardless of platinum sensitivity. Population studied will be female participants experiencing a 1st, 2nd, or 3rd recurrence of any stage epithelial ovarian cancer.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Ovarian Cancer
  • Official Title: Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients With Recurrent Platinum-Resistant or -Sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Clinical Trial IDs

  • ORG STUDY ID: CG02EOC
  • NCT ID: NCT03632798

Conditions

  • Recurrent Ovarian Cancer

Interventions

DrugSynonymsArms
ChemotherapyList of cytotoxic chemotherapy drugsPhysician Choice treatment

Purpose

The purpose of this randomized clinical study is to confirm the utility of chemosensitivity (ChemoID) tumor testing on cancer stem cells as a predictor of clinical response in recurrent epithelial ovarian cancer (EOC), fallopian tube, or primary peritoneal cancer, regardless of platinum sensitivity. Population studied will be female participants experiencing a 1st, 2nd, or 3rd recurrence of any stage epithelial ovarian cancer.

Detailed Description

      This study is designed as a parallel group randomized controlled clinical trial to determine
      if recurrent Epithelial Ovarian Cancer (EOC) patients treated with Bevacizumab plus drugs
      predicted by the ChemoID assay will have better outcomes than patients treated with
      standard-of-care control therapy (Bevacizumab plus chemotherapy chosen by the Physician).

      Upon obtaining informed consent, all eligible participants affected by 1st, 2nd, or 3rd
      relapse of EOC regardless of platinum sensitivity (both platinum sensitive and resistant)
      will have a tumor biopsy or a cancer-positive fluid collection sample to undergo ChemoID drug
      response testing with multiple FDA-approved chemotherapeutic agents.

      Eligible participants will be randomized to a standard treatment arm with control treatment
      (Bevacizumab plus chemotherapy chosen by the Physician from the provided list), or to a study
      arm of Bevacizumab plus FDA-approved drugs selected by the ChemoID drug response assay.

      A stratified randomization approach for treatment arm assignment will be used with strata
      based on relapse number, platinum sensitivity, and study site to ensure balance within these
      cells.
    

Trial Arms

NameTypeDescriptionInterventions
Physician Choice treatmentActive ComparatorParticipants will be treated with control chemotherapy treatment (Bevacizumab plus standard-of-care chemotherapy chosen by the Physician from the provided list). Control chemotherapy treatment will be chosen from any of the following standard-of-care chemotherapy drugs or combinations: Liposomal Doxorubicin; Docetaxel; Paclitaxel; Carboplatin; Cisplatin; Gemcitabine; Topotecan; Carboplatin, Gemcitabine; Cisplatin, Gemcitabine; Carboplatin, Liposomal Doxorubicin; Carboplatin, Paclitaxel; Carboplatin, Docetaxel. The treating physician will NOT receive the ChemoID assay results from the ChemoID lab.
  • Chemotherapy
ChemoID-guided treatmentExperimentalParticipants will be treated with Bevacizumab plus ChemoID-guided standard-of-care chemotherapy drugs from the provided list. ChemoID-guided treatment will be chosen from the following standard-of-care chemotherapy drugs or combinations: Liposomal Doxorubicin; Docetaxel; Paclitaxel; Carboplatin; Cisplatin; Gemcitabine; Topotecan; Carboplatin, Gemcitabine; Cisplatin, Gemcitabine; Carboplatin, Liposomal Doxorubicin; Carboplatin, Paclitaxel; Carboplatin, Docetaxel. The treating physician will receive the ChemoID assay results from the ChemoID lab.
  • Chemotherapy

Eligibility Criteria

        Inclusion Criteria:

          -  1. Informed consent obtained and signed;

          -  2. Willing and able to commit to study procedures including long-term follow-up
             visit(s);

          -  3. At least 18 years old at the time of enrollment;

          -  4. Negative pregnancy test for women of childbearing potential

          -  5. Experiencing 1st, 2nd, or 3rd recurrent epithelial ovarian cancer of any stage
             regardless of platinum sensitivity, (platinum-sensitive, -resistant, or -refractory);

          -  6. Histopathological or cytological confirmation of recurrent epithelial ovarian
             carcinoma, peritoneal cancer or fallopian tube cancer.

          -  7. Evaluable disease - defined as RECIST 1.1 measurable disease OR not measurable
             disease (defined as solid and/or cystic abnormalities on radiographic imaging that do
             not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion
             that has been pathologically demonstrated to be disease-related in the setting of a
             CA125 > 2x ULN).

          -  8. At least 30 days post-cytotoxic chemotherapy and/or monoclonal antibody therapy
             prior to enrollment;

          -  9. Toxicities of prior therapy (excepting alopecia) should be resolved to less than or
             equal to Grade 1 as per CTCAE v4.0 (http://ctep.cancer.gov/protocol
             development/electronic_applications/ctc.htm). Patients with long-standing stable grade
             2 neuropathy may be considered after discussion with the Study Chair.

          -  10. ECOG Performance Status Score of ≤ 2, KPS≥70, or 0-1 GOG status

          -  11. Adequate laboratory values within 60 days of enrollment to study defined as
             follows:

               1. WBC ≥ 3000/mm3

               2. Hgb ≥ 10 mg/dl

               3. Hct ≥ 28%

               4. Platelet count ≥ 100,000/μL

               5. Serum creatinine ≤ 2.0 mg/dl

               6. Total bilirubin ≤ 2.5 mg/dl

               7. AST/SGOT ≤ 3 times ULN. If intrahepatic liver metastases are present, AST and ALT
                  must be ≤ 5 times institutional ULN.

               8. Random urine protein/creatinine ratio ≤ 1 or 24 hour urine protein < 0.1 gram.

          -  12. Appropriate for tissue sampling either by tumor biopsy or peritoneal or pleural
             fluid collection.

        Exclusion Criteria:

          -  1. Estimated life expectancy of <6 months, as estimated by the investigator in
             consultation with participating oncologists;

          -  2. Ovarian cancer of a low grade serous, mucinous, or clear cell histology;

          -  3. Uncontrolled diabetes;

          -  4. Patients with clinically significant proteinuria; urine protein should be screened
             by urine protein-creatinine ratio (UPCR); the UPCR has been found to correlate
             directly with the amount of protein excreted in a 24 hour urine collection;
             specifically, a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24-hour urine
             collection; obtain at least 4 ml of a random urine sample in a sterile container (does
             not have to be a 24-hour urine); send sample to lab with request for urine protein and
             creatinine levels (separate requests); the lab will measure protein concentration
             (mg/dL) and creatinine concentration (mg/dL); the UPCR is derived as follows: protein
             concentration (mg/dL)/creatinine (mg/dL); patients must have a UPCR ≤ 1.0 to allow
             participation in the study;

          -  5. Symptomatic cardiac conditions;

          -  6. Contraindications to bevacizumab including uncontrolled hypertension, known
             arterial or venous thromboembolism, known nephrotic syndrome, history of abdominal
             fistula, GIP, or intra-abdominal abscess; clinical signs or symptoms of GI obstruction
             and/or requirement for parenteral hydration or nutrition; nonhealing wound, ulcer, or
             bone fracture; bleeding diathesis or significant coagulopathy; known CNS disease,
             clinically significant cardiovascular disease; and a major surgical procedure within
             28 days of enrollment or anticipated to occur while participating in study;

          -  7. Enrollment in another clinical study that precludes allowing the oncologist to
             select chemotherapy regimens;

          -  8. Previously participated in this study;

          -  9. Any condition that would, in the opinion of the investigator, place the participant
             at an unacceptable risk, or render the participant unable to meet the requirements of
             the protocol (including long-term study follow-up).

          -  10. Documented history of ovarian cancer of a low malignant potential phenotype or
             unclear cell histology.

          -  11. CA-125 only disease without RECIST 1.1 measurable or otherwise evaluable disease

          -  12. Patients may not use any complementary or alternative medicines including natural
             herbal products or folk remedies as they may interfere with the effectiveness of the
             study treatments.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression free survival (PFS)
Time Frame:36 months
Safety Issue:
Description:Progression free survival (PFS) in patients with recurrent epithelial ovarian cancer (EOC) who receive standard of care treatment (Bevacizumab plus chemotherapy chosen by the Physician from the provided list) versus Bevacizumab plus ChemoID drug response assay-directed chemotherapy.

Secondary Outcome Measures

Measure:Median Overall Survival (OS)
Time Frame:36 months
Safety Issue:
Description:Overall survival (OS) in patients with recurrent EOC who receive standard of care treatment (Bevacizumab plus chemotherapy chosen by the Physician from the provided list) versus Bevacizumab plus ChemoID drug response assay-directed chemotherapy.
Measure:Objective Tumor Response
Time Frame:36 months
Safety Issue:
Description:ORR: partial or complete response by RECIST v1.1 (Response Evaluation Criteria In Solid Tumors)
Measure:HRQOL
Time Frame:36 months
Safety Issue:
Description:Health-Related Quality of Life (HRQOL)

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Cordgenics, LLC

Trial Keywords

  • ChemoID
  • cancer stem cells
  • drug response assay
  • ovarian cancer

Last Updated

January 6, 2019