Avatar-Directed Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
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| ClinicalTrials.gov Identifier: NCT02312245 |
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Recruitment Status :
Recruiting
First Posted : December 9, 2014
Last Update Posted : June 28, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma | Biological: Bevacizumab Drug: Gemcitabine Hydrochloride Drug: Paclitaxel Drug: Pegylated Liposomal Doxorubicin Hydrochloride Drug: Topotecan Hydrochloride | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 240 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Avatar-Directed Chemotherapy in Platinum-Resistant Ovarian, Primary Peritoneal and Fallopian Tube Cancers |
| Actual Study Start Date : | July 21, 2015 |
| Estimated Primary Completion Date : | July 1, 2023 |
| Estimated Study Completion Date : | July 15, 2023 |
| Arm | Intervention/treatment |
|---|---|
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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
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Biological: Bevacizumab
Given IV
Other Names:
Drug: Paclitaxel Given IV
Other Names:
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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.
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Drug: Gemcitabine Hydrochloride
Given IV
Other Names:
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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.
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Biological: Bevacizumab
Given IV
Other Names:
Drug: Pegylated Liposomal Doxorubicin Hydrochloride Given IV
Other Names:
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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.
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Biological: Bevacizumab
Given IV
Other Names:
Drug: Topotecan Hydrochloride Given IV
Other Names:
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- Proportion 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 ]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.
- Incidence of adverse events (AE) [ Time Frame: Up to 3 years ]Maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine AE patterns.
- Overall survival (OS) [ Time Frame: Time from registration to death from any cause, assessed up to 3 years ]OS will be estimated using the method of Kaplan-Meier.
- Progression free survival (PFS) [ Time Frame: Time from registration to the first of either disease progression or death from any cause, assessed up to 3 years ]PFS will be estimated using the method of Kaplan-Meier.
- Response rates [ Time Frame: Up to 3 years ]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 (bevacizumab or no bevacizumab).
- Enriched Avatar response signature in response to Avatar-directed therapy using patient outcomes [ Time Frame: Up to 3 years ]This will be an exploratory analysis that will use the outcome data from this trial to inform future work using Avatar directed therapy.
- Frequency (%) of patients who had an Avatar response and a clinical tumor response for the same treatment [ Time Frame: Up to 3 years ]Overall concordance rate and confidence interval will be reported.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologic confirmation of ovarian, primary peritoneal or fallopian tube cancer of any subtype
- Prior consent to have tumors used for unspecified future research
- Ability to provide written informed consent
- Willing to agree to periodic contact with a member of the study team during the period that the cancer has not recurred and/or has not become platinum resistant
- Willing to agree that the local medical oncologist may be informed that patient has agreed to participate in the study
- Platinum resistant or refractory ovarian, primary peritoneal or fallopian tube cancer of any subtype; Note: platinum-sensitive disease is allowed in cases where there is a contraindication to platinum-based therapy (i.e., allergy to platinum); this must be reviewed and approved by the Principal Investigator
- Successful Avatar engraftment with successful expansion and treatment outcome of Avatar therapy
- Eastern Cooperative Oncology Group (ECOG) performance status (ECOG performance status [PS]) of 0, 1 or 2
- Measurable disease or non-measurable disease; for patients with non-measureable disease, they must also have a cancer antigen (CA)-125 measurement of > 35 U/mL or 2 X their documented nadir on 2 separate measurements 1 week apart
- The following laboratory values obtained =< 21 days prior to registration; complete blood count (CBC), sodium, potassium, aspartate aminotransferase (AST), bilirubin and creatinine are to be obtained pre-study; Note: treatment initiation and dosing modification should be performed at the individual investigators discretion and be consistent with the product label and their medical practice
- Negative urine or serum pregnancy test performed =< 7 days prior to registration, for women of child bearing potential only
- Willing to return to enrolling institution for follow-up or have a local physician willing to submit response and outcome data; Note: any and all therapy, potentially in its entirety, may be conducted outside of the Mayo Clinic
Exclusion Criteria:
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Any of the following:
- Pregnant women
- Nursing women
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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:
- Therapeutic antibodies, such as bevacizumab
- Small molecule kinase inhibitors, such as pazopanib
- Vaccines and immunotherapy All of these exceptions should be confirmed with the Principal Investigator (PI) prior to registration
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; Note: patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
- Uncontrolled intercurrent illness judged by the treating investigator to preclude treatment with chemotherapy
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Other active malignancy =< 3 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; Note: if there is a history of prior malignancy, they must not be receiving treatment for their cancer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02312245
| United States, Arizona | |
| Mayo Clinic | Recruiting |
| Phoenix, Arizona, United States, 85054 | |
| Contact: Clinical Trials Referral Office 855-776-0015 | |
| Principal Investigator: John K. Camoriano | |
| United States, Florida | |
| Mayo Clinic | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Clinical Trials Referral Office 855-776-0015 | |
| Principal Investigator: Gerardo Colon-Otero | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Referral Office 855-776-0015 | |
| Principal Investigator: Saravut J. Weroha | |
| Principal Investigator: | Saravut Weroha | Mayo Clinic |
| Responsible Party: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT02312245 |
| Other Study ID Numbers: |
MC1463 NCI-2014-02399 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) Mod14-002986-03 MC1463 ( Other Identifier: Mayo Clinic ) R01CA184502 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 9, 2014 Key Record Dates |
| Last Update Posted: | June 28, 2022 |
| Last Verified: | June 2022 |
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Carcinoma Fallopian Tube Neoplasms Recurrence Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Disease Attributes Pathologic Processes Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Fallopian Tube Diseases Adnexal Diseases Gemcitabine Paclitaxel |
Bevacizumab Doxorubicin Liposomal doxorubicin Albumin-Bound Paclitaxel Topotecan Antineoplastic Agents, Immunological Endothelial Growth Factors Antibodies Immunoglobulins Antibodies, Monoclonal Immunoglobulin G Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents |