Nab-Paclitaxel and Bevacizumab in Treating Patients With Unresectable Stage IV Melanoma or Gynecological Cancers

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT02020707
Phase
PHASE1
Status
Completed

Conditions

  • Cervical Adenocarcinoma
  • Cervical Adenosarcoma
  • Cervical Adenosquamous Carcinoma
  • Cervical Carcinosarcoma
  • Cervical Squamous Cell Carcinoma
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Endometrial Adenosquamous Carcinoma
  • Endometrial Clear Cell Adenocarcinoma
  • Endometrial Endometrioid Adenocarcinoma
  • Endometrial Mixed Cell Adenocarcinoma
  • Endometrial Mucinous Adenocarcinoma
  • Endometrial Serous Adenocarcinoma
  • Endometrial Undifferentiated Carcinoma
  • Fallopian Tube Adenocarcinoma
  • Fallopian Tube Carcinosarcoma
  • Fallopian Tube Clear Cell Adenocarcinoma
  • Fallopian Tube Endometrioid Adenocarcinoma
  • Fallopian Tube Mucinous Adenocarcinoma
  • Fallopian Tube Serous Adenocarcinoma
  • Fallopian Tube Squamous Cell Carcinoma
  • Fallopian Tube Transitional Cell Carcinoma
  • Fallopian Tube Undifferentiated Carcinoma
  • Malignant Female Reproductive System Neoplasm
  • Malignant Ovarian Clear Cell Tumor
  • Malignant Ovarian Endometrioid Tumor
  • Malignant Ovarian Epithelial Tumor
  • Malignant Ovarian Mucinous Tumor
  • Malignant Peritoneal Neoplasm
  • Malignant Solid Neoplasm
  • Ovarian Carcinosarcoma
  • Ovarian Clear Cell Adenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian High Grade Serous Adenocarcinoma
  • Ovarian Mucinous Adenocarcinoma
  • Ovarian Serous Adenocarcinoma
  • Ovarian Transitional Cell Carcinoma
  • Ovarian Undifferentiated Carcinoma
  • Platinum-Resistant Fallopian Tube Carcinoma
  • Platinum-Resistant Ovarian Carcinoma
  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Platinum-Sensitive Ovarian Carcinoma
  • Primary Peritoneal Carcinosarcoma
  • Primary Peritoneal Clear Cell Adenocarcinoma
  • Primary Peritoneal Serous Adenocarcinoma
  • Primary Peritoneal Transitional Cell Carcinoma
  • Primary Peritoneal Undifferentiated Carcinoma
  • Unresectable Melanoma
  • Uterine Corpus Carcinosarcoma

Eligibility Criteria

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

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nab-paclitaxel — DRUG
    Given IV
  • Pharmacological Study — OTHER
    Correlative studies

Study Details

This phase I trial studies the side effects and best dose of nab-paclitaxel and bevacizumab in treating patients with stage IV melanoma that cannot be removed by surgery (unresectable), cancer of the cervix, endometrium, ovary, fallopian tube or peritoneal cavity. Drugs used in chemotherapy, such as nab-paclitaxel, 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. Bevacizumab may stop or slow tumor growth by blocking the growth of new blood vessels necessary for tumor growth. Giving nab paclitaxel and bevacizumab may kill more tumor cells than nab-paclitaxel alone.

Key Dates

First listed
Dec 25, 2013
Start date
Feb 24, 2014
Status verified
Jul 2024
Primary completion
Jul 18, 2024
Completion
Jul 18, 2024

Study Design

Enrollment
43 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (AB-complex)
    Patients receive nab-paclitaxel/bevacizumab-complex IV over 30-60 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patient may receive paclitaxel if supply of nab-paclitaxel is exhausted.

Primary Outcome Measure

Maximum tolerated dose (MTD [ Time Frame: 28 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Mayo Clinic Hospital in ArizonaPhoenixArizona85054-
Mayo Clinic in ArizonaScottsdaleArizona85259-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Phoenix, AZ

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

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