A Phase 2 interventional study of Bevacizumab and Gemcitabine Hydrochloride in Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma and Recurrent Primary Peritoneal Carcinoma, sponsored by Mayo Clinic. Completed at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
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.
PRIMARY OBJECTIVES:
I. To determine the response rate of Avatar-directed salvage chemotherapy in patients with platinum-resistant ovarian, primary peritoneal and fallopian tube cancers.
SECONDARY OBJECTIVES:
I. To determine the progression-free survival of patients with platinum-resistant ovarian, primary peritoneal and fallopian tube cancers receiving Avatar-directed salvage chemotherapy.
II. To determine the overall survival of patients with platinum-resistant ovarian, primary peritoneal and fallopian tube cancers receiving Avatar-directed salvage chemotherapy.
III. To determine the adverse events for patients with platinum-resistant ovarian, primary peritoneal and fallopian tube cancers receiving Avatar-directed salvage chemotherapy.
IV. To determine the correlation between patient response and response in their Avatar.
V. To enrich the Avatar response signature in response to Avatar-directed therapy using patient outcomes.
VI. To compare the response rates between patients who did or did not receive bevacizumab treatment.
OUTLINE: Patients are assigned to 1 of 4 treatment arms as directed by Avatar results.
ARM A: Patients receive paclitaxel intravenously (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
ARM B: 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.
ARM C: 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.
ARM D: 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.
After completion of study treatment, patients are followed up every 3-6 months for 3 years.
734 studies on the registry are indexed under Fallopian Tube Neoplasms; 128 are open to participants now.
This study's enrollment of 13 is below the median of 51 across 598 interventional studies indexed under Fallopian Tube Neoplasms.
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Exclusion Criteria:
Any of the following:
Prior treatment with Doxil, topotecan, Gemzar or Taxol chemotherapy for platinum-resistant cancer; Note: Allowed prior therapy with Doxil or Gemzar if given for platinum sensitive disease in combination with a platinum drug AND the Avatar data indicates a drug other than Doxil or Gemzar would be effective; Note: Allowed prior therapies for patients following confirmation of platinum-resistant cancer include:
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
Biological: Bevacizumab · Drug: Paclitaxel
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.
Drug: Gemcitabine Hydrochloride
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.
Biological: Bevacizumab · Drug: Pegylated Liposomal Doxorubicin 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.
Biological: Bevacizumab · Drug: Topotecan Hydrochloride
Given IV
Also known as: Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF
Given IV
Also known as: dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011, LY188011
Given IV
Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Given IV
Also known as: ATI-0918, Caelyx, DOX-SL, Doxil, Doxilen, Doxorubicin HCl Liposome, Doxorubicin Hydrochloride Liposome, Duomeisu, Evacet, LipoDox, Liposomal Adriamycin, Liposomal Doxorubicin Hydrochloride, Liposomal-Encapsulated Doxorubicin, Pegylated Doxorubicin HCl Liposome, S-Liposomal Doxorubicin, Stealth Liposomal Doxorubicin, TLC D-99
Given IV
Also known as: Hycamptamine, Hycamtin, SKF S-104864-A, Topotecan HCl, topotecan hydrochloride (oral)
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
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.
Time frame: 24 weeks
Number of Patients Experiencing Grade 3+ Adverse Events (AE)
Maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine AE patterns.
Time frame: 9 months
Overall Survival (OS)
OS will be estimated using the method of Kaplan-Meier. Analysis will be conducted with all arms of Avatar-directed chemotherapy pooled.
Time frame: 25 months
Progression Free Survival (PFS)
PFS will be estimated using the method of Kaplan-Meier. Analysis will be conducted with all arms of Avatar-directed chemotherapy pooled.
Time frame: 9 months
Number of Patients With a Partial or Confirmed Response
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.
Time frame: 9 months
Enriched Avatar Response Signature in Response to Avatar-directed Therapy Using Patient Outcomes
This will be an exploratory analysis that will use the outcome data from this trial to inform future work using Avatar directed therapy.
Time frame: Up to 3 years
Frequency (%) of Patients Who Had an Avatar Response and a Clinical Tumor Response for the Same Treatment
Overall concordance rate and confidence interval will be reported.
Time frame: Up to 3 years
| Milestone | Arm A (Avatar-directed Paclitaxel) | Arm B (Avatar-directed Gemcitabine Hydrochloride) | Arm C (Avatar-directed Liposomal Doxorubicin) | Arm D (Avatar-directed Topotecan Hydrochloride) |
|---|---|---|---|---|
| Started | 3 | 1 | 0 | 9 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 3 | 1 | 0 | 9 |
| Withdrew: Death | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 | 2 |
| Withdrew: Alternative therapy | 1 | 0 | 0 | 0 |
| Withdrew: Progression | 0 | 0 | 0 | 5 |
| Withdrew: Patient went to hospice | 0 | 0 | 0 | 1 |
| Withdrew: Ineligible | 1 | 0 | 0 | 0 |
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.
| Participants | Arm A (Avatar-directed Paclitaxel) | Arm B (Avatar-directed Gemcitabine Hydrochloride) | Arm D (Avatar-directed Topotecan Hydrochloride) |
|---|---|---|---|
| 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 | 0 | 0 | 0 |
Maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine AE patterns.
| Participants | Arm A (Avatar-directed Paclitaxel) | Arm B (Avatar-directed Gemcitabine Hydrochloride) | Arm D (Avatar-directed Topotecan Hydrochloride) |
|---|---|---|---|
| Number of Patients Experiencing Grade 3+ Adverse Events (AE) | 1 | 1 | 4 |
OS will be estimated using the method of Kaplan-Meier. Analysis will be conducted with all arms of Avatar-directed chemotherapy pooled.
| months | Arm A (Avatar-directed Paclitaxel) | Arm B (Avatar-directed Gemcitabine Hydrochloride) | Arm D (Avatar-directed Topotecan Hydrochloride) |
|---|---|---|---|
| Overall Survival (OS) | 7.9 (NA to NA) | 8.7 (NA to NA) | 9.2 (4.5 to NA) |
PFS will be estimated using the method of Kaplan-Meier. Analysis will be conducted with all arms of Avatar-directed chemotherapy pooled.
| months | Arm A (Avatar-directed Paclitaxel) | Arm B (Avatar-directed Gemcitabine Hydrochloride) | Arm D (Avatar-directed Topotecan Hydrochloride) |
|---|---|---|---|
| Progression Free Survival (PFS) | 7.9 (NA to NA) | 8.7 (NA to NA) | 3.0 (1.9 to NA) |
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.
| Participants | Arm A (Avatar-directed Paclitaxel) | Arm B (Avatar-directed Gemcitabine Hydrochloride) | Arm D (Avatar-directed Topotecan Hydrochloride) |
|---|---|---|---|
| Number of Patients With a Partial or Confirmed Response | 0 | 0 | 0 |
This will be an exploratory analysis that will use the outcome data from this trial to inform future work using Avatar directed therapy.
Results for this outcome have not been posted.
Overall concordance rate and confidence interval will be reported.
Results for this outcome have not been posted.
Collected over 25 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A (Avatar-directed Paclitaxel) | 1/2 (50%) | 1/2 (50%) | 1/2 (50%) |
| Arm B (Avatar-directed Gemcitabine Hydrochloride) | 1/1 (100%) | 0/1 (0%) | 1/1 (100%) |
| Arm D (Avatar-directed Topotecan Hydrochloride) | 6/9 (66.7%) | 3/9 (33.3%) | 4/9 (44.4%) |
| Event | Arm A (Avatar-directed Paclitaxel) | Arm B (Avatar-directed Gemcitabine Hydrochloride) | Arm D (Avatar-directed Topotecan Hydrochloride) |
|---|---|---|---|
| Skin infectionInfections and infestations | 1/2 | 0/1 | 0/9 |
| ConfusionPsychiatric disorders | 1/2 | 0/1 | 0/9 |
| Colonic obstructionGastrointestinal disorders | 0/2 | 0/1 | 1/9 |
| Gastric perforationGastrointestinal disorders | 0/2 | 0/1 | 1/9 |
| Creatinine increasedInvestigations | 0/2 | 0/1 | 1/9 |
| HyponatremiaMetabolism and nutrition disorders | 0/2 | 0/1 | 1/9 |
| Neoplasms benign, mal, uncpec - Oth specNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/2 | 0/1 | 1/9 |
| AnemiaBlood and lymphatic system disorders | 0/2 | 0/1 | 0/9 |
| Neutrophil count decreasedInvestigations | 0/2 | 0/1 | 0/9 |
| Event | Arm A (Avatar-directed Paclitaxel) | Arm B (Avatar-directed Gemcitabine Hydrochloride) | Arm D (Avatar-directed Topotecan Hydrochloride) |
|---|---|---|---|
| Neutrophil count decreasedInvestigations | 1/2 | 1/1 | 0/9 |
| AnemiaBlood and lymphatic system disorders | 1/2 | 0/1 | 2/9 |
| FatigueGeneral disorders | 1/2 | 0/1 | 1/9 |
| DehydrationMetabolism and nutrition disorders | 1/2 | 0/1 | 0/9 |
| AlopeciaSkin and subcutaneous tissue disorders | 1/2 | 0/1 | 1/9 |
| DiarrheaGastrointestinal disorders | 0/2 | 0/1 | 2/9 |
| ConstipationGastrointestinal disorders | 0/2 | 0/1 | 1/9 |
| Alkaline phosphatase increasedInvestigations | 0/2 | 0/1 | 1/9 |
| Lymphocyte count decreasedInvestigations | 0/2 | 0/1 | 1/9 |
All patients that were enrolled were analyzed
| Age, Continuous(years) | Arm A (Avatar-directed Paclitaxel) | Arm B (Avatar-directed Gemcitabine Hydrochloride) | Arm C (Avatar-directed Liposomal Doxorubicin) | Arm D (Avatar-directed Topotecan Hydrochloride) | Total |
|---|---|---|---|---|---|
| Mean | 61 ± 8.54 | 32 ± NA | — | 56.6 ± 8.22 | 55.7 ± 10.56 |
| Sex: Female, Male(Participants) | Arm A (Avatar-directed Paclitaxel) | Arm B (Avatar-directed Gemcitabine Hydrochloride) | Arm C (Avatar-directed Liposomal Doxorubicin) | Arm D (Avatar-directed Topotecan Hydrochloride) | Total |
|---|---|---|---|---|---|
| Female | 3 | 1 | — | 9 | 13 |
| Male | 0 | 0 | — | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Arm A (Avatar-directed Paclitaxel) | Arm B (Avatar-directed Gemcitabine Hydrochloride) | Arm C (Avatar-directed Liposomal Doxorubicin) | Arm D (Avatar-directed Topotecan Hydrochloride) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | — | 0 | 0 |
| Not Hispanic or Latino | 3 | 1 | — | 9 | 13 |
| Unknown or Not Reported | 0 | 0 | — | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm A (Avatar-directed Paclitaxel) | Arm B (Avatar-directed Gemcitabine Hydrochloride) | Arm C (Avatar-directed Liposomal Doxorubicin) | Arm D (Avatar-directed Topotecan Hydrochloride) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | — | 0 | 0 |
| Asian | 0 | 0 | — | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | — | 0 | 0 |
| Black or African American | 0 | 0 | — | 0 | 0 |
| White | 3 | 1 | — | 8 | 12 |
| More than one race | 0 | 0 | — | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | — | 0 | 0 |
| Region of Enrollment(participants) | Arm A (Avatar-directed Paclitaxel) | Arm B (Avatar-directed Gemcitabine Hydrochloride) | Arm C (Avatar-directed Liposomal Doxorubicin) | Arm D (Avatar-directed Topotecan Hydrochloride) | Total |
|---|---|---|---|---|---|
| United States | 3 | 1 | — | 9 | 13 |
| Tumor Histology Type(Participants) | Arm A (Avatar-directed Paclitaxel) | Arm B (Avatar-directed Gemcitabine Hydrochloride) | Arm C (Avatar-directed Liposomal Doxorubicin) | Arm D (Avatar-directed Topotecan Hydrochloride) | Total |
|---|---|---|---|---|---|
| Ovarian (serous) | 3 | 1 | — | 7 | 11 |
| Fallopian tube (serous) | 0 | 0 | — | 1 | 1 |
| Ovarian (other) | 0 | 0 | — | 1 | 1 |
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Studies of the drugs tested here: Bevacizumab · Gemcitabine · Paclitaxel · Liposomal doxorubicin · Topotecan