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NCT02312245

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

Completed Phase 2 Results posted Last updated 5 December 2024
What this trial tests

Phase 2 trial testing Bevacizumab in Recurrent Fallopian Tube Carcinoma in 13 participants. Completed in 24 April 2023.

Timeline
21 July 2015
Primary endpoint
24 April 2023
24 April 2023

Quick facts

Lead sponsorMayo Clinic
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment13
Start date21 July 2015
Primary completion24 April 2023
Estimated completion24 April 2023
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mayo Clinic

Who can join

18 and older, female only, with Recurrent Fallopian Tube Carcinoma or Recurrent Ovarian Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 24 weeks

Estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the exact Binomial method. The primary analysis will pool across all patients, and tumor response rate by treatment arm will also be looked at in an exploratory fashion.

GroupValue95% CI
Arm A (Avatar-directed Paclitaxel)0
Arm B (Avatar-directed Gemcitabine Hydrochloride)0
Arm D (Avatar-directed Topotecan Hydrochloride)0
Number of Patients Experiencing Grade 3+ Adverse Events (AE) Secondary · 9 months

Maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine AE patterns.

GroupValue95% CI
Arm A (Avatar-directed Paclitaxel)1
Arm B (Avatar-directed Gemcitabine Hydrochloride)1
Arm D (Avatar-directed Topotecan Hydrochloride)4
Overall Survival (OS) Secondary · 25 months

OS will be estimated using the method of Kaplan-Meier. Analysis will be conducted with all arms of Avatar-directed chemotherapy pooled.

GroupValue95% CI
Arm A (Avatar-directed Paclitaxel)7.9NA – NA
Arm B (Avatar-directed Gemcitabine Hydrochloride)8.7NA – NA
Arm D (Avatar-directed Topotecan Hydrochloride)9.24.5 – NA
Progression Free Survival (PFS) Secondary · 9 months

PFS will be estimated using the method of Kaplan-Meier. Analysis will be conducted with all arms of Avatar-directed chemotherapy pooled.

GroupValue95% CI
Arm A (Avatar-directed Paclitaxel)7.9NA – NA
Arm B (Avatar-directed Gemcitabine Hydrochloride)8.7NA – NA
Arm D (Avatar-directed Topotecan Hydrochloride)3.01.9 – NA
Number of Patients With a Partial or Confirmed Response Secondary · 9 months

The Chi-square or Fisher's Exact test will be used to compare the response rates between patients who did or did not receive bevacizumab treatment. The response rates will also be reported by treatment type.

GroupValue95% CI
Arm A (Avatar-directed Paclitaxel)0
Arm B (Avatar-directed Gemcitabine Hydrochloride)0
Arm D (Avatar-directed Topotecan Hydrochloride)0

Adverse events — posted to ClinicalTrials.gov

Time frame: 25 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm A (Avatar-directed Paclitaxel)
Serious: 1/2 (50%)
Deaths: 1/2
Arm B (Avatar-directed Gemcitabine Hydrochloride)
Serious: 0/1 (0%)
Deaths: 1/1
Arm D (Avatar-directed Topotecan Hydrochloride)
Serious: 3/9 (33%)
Deaths: 6/9

Serious adverse events (9 terms)

ReactionSystemArm A (Avatar-directed Pac…Arm B (Avatar-directed Gem…Arm D (Avatar-directed Top…
Colonic obstructionGastrointestinal disorders
Gastric perforationGastrointestinal disorders
Skin infectionInfections and infestations
Creatinine increasedInvestigations
HyponatremiaMetabolism and nutrition disorders
Neoplasms benign, mal, uncpec - Oth specNeoplasms benign, malignant and unspecified (incl cysts and polyps)
ConfusionPsychiatric disorders
AnemiaBlood and lymphatic system disorders
Neutrophil count decreasedInvestigations
Other adverse events (9 terms — click to expand)

ReactionSystemArm A (Avatar-directed Pac…Arm B (Avatar-directed Gem…Arm D (Avatar-directed Top…
AnemiaBlood and lymphatic system disorders
DiarrheaGastrointestinal disorders
ConstipationGastrointestinal disorders
FatigueGeneral disorders
Alkaline phosphatase increasedInvestigations
Lymphocyte count decreasedInvestigations
Neutrophil count decreasedInvestigations
DehydrationMetabolism and nutrition disorders
AlopeciaSkin and subcutaneous tissue disorders

Most-reported serious reactions: Colonic obstruction, Gastric perforation, Skin infection, Creatinine increased, Hyponatremia, Neoplasms benign, mal, uncpec - Oth spec, Confusion, Anemia.

Data from ClinicalTrials.gov NCT02312245 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Integrated Patient-Derived Models Delineate Individualized Therapeutic Vulnerabilities of Pancreatic Cancer.
    Witkiewicz AK, Balaji U, Eslinger C, McMillan E, et al · · 2016 · cited 78× · PMID 27498862 · DOI 10.1016/j.celrep.2016.07.023
  2. Prevention of Human Lymphoproliferative Tumor Formation in Ovarian Cancer Patient-Derived Xenografts.
    Butler KA, Hou X, Becker MA, Zanfagnin V, et al · · 2017 · cited 54× · PMID 28658648 · DOI 10.1016/j.neo.2017.04.007
  3. Gene expression differences between matched pairs of ovarian cancer patient tumors and patient-derived xenografts.
    Liu Y, Chanana P, Davila JI, Hou X, et al · · 2019 · cited 37× · PMID 31004097 · DOI 10.1038/s41598-019-42680-2
  4. Current and Future Horizons of Patient-Derived Xenograft Models in Colorectal Cancer Translational Research.
    Inoue A, Deem AK, Kopetz S, Heffernan TP, et al · · 2019 · cited 31× · PMID 31500168 · DOI 10.3390/cancers11091321
  5. Overcoming the challenges of drug development in platinum-resistant ovarian cancer.
    Eskander RN, Moore KN, Monk BJ, Herzog TJ, et al · · 2023 · cited 24× · PMID 37916177 · DOI 10.3389/fonc.2023.1258228
  6. Statistical analysis of comparative tumor growth repeated measures experiments in the ovarian cancer patient derived xenograft (PDX) setting.
    Oberg AL, Heinzen EP, Hou X, Al Hilli MM, et al · · 2021 · cited 24× · PMID 33850213 · DOI 10.1038/s41598-021-87470-x
  7. Precision oncology using ex vivo technology: a step towards individualised cancer care?
    Williams ST, Wells G, Conroy S, Gagg H, et al · · 2022 · cited 14× · PMID 36184897 · DOI 10.1017/erm.2022.32
  8. CD24-targeted fluorescence imaging in patient-derived xenograft models of high-grade serous ovarian carcinoma.
    Kleinmanns K, Bischof K, Anandan S, Popa M, et al · · 2020 · cited 13× · PMID 32454401 · DOI 10.1016/j.ebiom.2020.102782

Verify or expand the search:

Other trials of Bevacizumab

Trials testing the same drug.

Other recruiting trials for Recurrent Fallopian Tube Carcinoma

Currently open trials in the same condition.

Other Mayo Clinic trials

Trials by the same sponsor.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02312245.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing