Avatar-Directed Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT02312245
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Gemcitabine Hydrochloride — DRUG
    Given IV
  • Paclitaxel — DRUG
    Given IV
  • Pegylated Liposomal Doxorubicin Hydrochloride — DRUG
    Given IV
  • Topotecan Hydrochloride — DRUG
    Given IV

Study Details

This phase II trial studies how well Avatar-directed chemotherapy works in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that does not respond to platinum anti-cancer drugs. Drugs used in chemotherapy, such as paclitaxel, gemcitabine hydrochloride, pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Using an Avatar, a living tumor sample with similar genetic characteristics to the original tumor, may help determine which chemotherapy is most effective.

Key Dates

First listed
Dec 9, 2014
Start date
Jul 21, 2015
Status verified
Nov 2024
Primary completion
Apr 24, 2023
Completion
Apr 24, 2023

Study Design

Enrollment
13 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (Avatar-directed paclitaxel)
    Patients receive paclitaxel IV over 1-96 hours on days 1, 8, and 15. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
  • Experimental: Arm B (Avatar-directed gemcitabine hydrochloride)
    Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm C (Avatar-directed liposomal doxorubicin)
    Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm D (Avatar-directed topotecan hydrochloride)
    Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 every 21 days or days 1, 8, and 15 every 28 days. Patients may also receive bevacizumab IV over 90 minutes on day 1 every 21 days or days 1 and 15 every 28 days. Courses repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Percentage of Patients With a Confirmed Tumor Response, Defined as Complete Response or Partial Response Estimated Using Response Evaluation Criteria in Solid Tumors 1.1 Criteria [ Time Frame: 24 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaPhoenixArizona85054-
Mayo Clinic in FloridaJacksonvilleFlorida32224-
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic in Arizona· Phoenix, AZMayo Clinic in Florida· Jacksonville, FLMayo Clinic in Rochester· Rochester, MN

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