Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab in Treating Patients with Stage IV Melanoma that Cannot be Removed by Surgery
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 13-001863
NCT ID: NCT02020707
Sponsor Protocol Number: MC1371
About this study
This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab many kill more tumor cells.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility criteria
For melanoma cohort only
- Histologic proof of surgically unresectable stage IV malignant melanoma.
- Measurable disease defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with chest x-ray, or as ≥1.0cm with CT scan or MRI scan; or CT component of a PET/CT.
- NOTE: Disease that is measurable by physical examination only is not eligible.
For gynecologic cancer cohort only
- Histologic proof of epithelial cervical, endometrial, ovarian, fallopian, or primary peritoneal cancers. Allowable histologies for cervical cancer include squamous cell carcinoma, adenocarcinoma, and mixed/adenosquamous carcinoma. Allowable histologies for endometrial cancer include endometrioid, serous, clear cell, mucinous, squamous, transitional cell, undifferentiated, mixed, and carcinosarcoma (this is considered a poorly differentiated epithelial tumor). Allowable histologies for ovarian, fallopian, and peritoneal cancer include serous, clear cell, endometrioid, mucinous, transitional cell, undifferentiated, mixed, and carcinosarcoma.
For ovarian, fallopian, and peritoneal cancers only
- Platinum-resistant, defined as ≤183 days from the date of the most recent dose of chemotherapy conaining either carboplatin or cisplatin until the first evidence of cancer recurrence or progression (either symptoms directly attributable to cancer, radiographic recurrence of cancer, or CA-125 >70, confirmed ≥7 days later (confirmation of elevated CA-125 may be beyond 183 days and still count as platinum-resistant).
- Measureable disease, defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with chest x-ray, or as ≥1.0cm with CT scan or MRI scan; or CT component of a PET/CT. NOTE: Disease that is measurable by physical examination only is not eligible.
- EXCEPTION: Patients with ovarian, fallopian, or peritoneal cancer,without measurable disease are eligible if two pretreatment.
- CA-125 values (documented on two occasions taken at least one week apart) are at least twice the upper limit of normal or twice the nadir value if pretreatment CA-125 values never normalized.
Remaining Inclusion Criteria apply to all participants:
- At least one prior systematic therapy in the metastatic setting.
- The following laboratory values obtained £14 days prior to registration:
- Hemoglobin ≥9.0 g/dL (patients may be transfused to meet Hgb requirement);
- ANC ³1500/mm3;
- PLT ³100,000/mm3;
- Total bilirubin £1.5 mg/dL or direct bilirubin ≤0.4 mg/dL;
- SGOT (AST) ≤2.5 x ULN;
- Creatinine £1.5 x ULN.
- Absence of proteinuria at screening as demonstrated by one of the following:
- Urine protein/creatinine (UPC) ratio <1.0 at screening; OR
- Urine dipstick for proteinuria <2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤1g of protein in 24 hours to be eligible).
- ECOG Performance Status (PS) 0 or 1 (Appendix I).
- Sensory peripheral neuropathy ≤Grade 1 (per CTCAE v. 4.0).
- Motor peripheral neuropathy = Grade 0 (per CTCAE v. 4.0.)
- Ability to understand and the willingness to sign a written informed consent document.
- Willing to return to enrolling institution for follow-up 2-4 weeks after treatment discontinuation.
- Life expectancy 90 days (3 months).
- Willing to provide blood samples for correlative research purposes (see Sections 6, 14 and 17).
- Negative pregnancy test done ≤7 days prior to registration, for women of childbearing potential only.
- Known standard therapy for the patient’s disease that is potentially curative or definitely capable of extending life expectancy.
- EXCEPTION: For platinum-resistant ovarian cancer, because Nab-paclitaxel has known benefit, patients who may benefit from standard single agent chemotherapy are also eligible to participate.
- Prior therapy with an angiogenesis inhibitor <8 weeks prior to registration.
- Any anti-cancer therapy or investigational agents ≤4 weeks prior to registration.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Failure to fully recover from acute, reversible effect of prior chemotherapy regardless of interval since last treatment.
- Brain metastases per MRI or CT at any time prior to registration.
- NOTE: patients that have had primary therapy for brain metastasis (i.e. surgical resection, whole brain radiation, or SRT even if stable) are not eligible.
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- Pregnant women;
- Nursing women;
- Men or women of childbearing potential who are unwilling to employ adequate contraception.
- 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.
- 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 other specific treatment for their cancer.
- Other medical conditions including but not limited to:
- History of liver disease such as cirrhosis, chronic active hepatitis, chronic persistent hepatitis or hepatitis B or C;
- Active infection requiring parenteral antibiotics;
- Immuno-compromised patients and patients known to be 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;
- New York Heart Association class II-IV congestive heart failure (Serious cardiac arrhythmia requiring medication);
- Myocardial infarction or unstable angina ≤6 months prior to registration;
- Congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias;
- Clinically significant peripheral vascular disease;
- History of CNS disease (e.g., primary brain tumor, vascular abnormalities, etc.), clinically significant stroke or TIA ≤6 months prior to registration, seizures not controlled with standard medical therapy;
- History of hypertensive crisis or hypertensive encephalopathy;
- Therapeutic anticoagulation requiring INR >2.0.
- For gynecologic cancer cohort only recurrent or progressive disease within 30 days of the last dose of weekly paclitaxel or Nab-paclitaxel.
- History of inflammatory bowel disease requiring ongoing therapy.
- History of diverticulitis or pancreatitis ≤6 months prior to registration.
- History of Grade 3 or 4 bowel toxicity from immune checkpoint inhibitor within 12 weeks of registration.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Svetomir Markovic, M.D., Ph.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office