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

NCT02020707 | Completed Phase 1 DMC FDA Drug

• 3 other identifiers: MC1371NCI-2013-0178213-001863
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 4

Brief Summary

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.

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

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD

  Defined as the highest dose level among those under consideration where at most 1 of 6 patients develops a dose-limiting toxicity.

  28 days

Secondary Outcomes (4)

• Tumor response

  Up to 12 months

• Progression-free survival (PFS)

  Time from study entry to the documentation of disease progression, assessed up to 12 months

• Overall survival (OS)

  Time from study entry to death due to any cause, assessed up to 12 months

• Incidence of adverse events (soft tissue expansion cohort)

  Up to 12 months

Study Arms (1)

Treatment (AB-complex)

EXPERIMENTAL

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.

Biological: Bevacizumab; Other: Laboratory Biomarker Analysis; Drug: Nab-paclitaxel; Other: Pharmacological Study

Interventions

Bevacizumab BIOLOGICAL

Given IV

Also known as: ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04, Anti-VEGF rhuMAb, Avastin, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-awwb, Bevacizumab-bvzr, BP102, BP102 Biosimilar, HD204, 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, Mvasi, MYL-1402O, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, SIBP 04, SIBP-04, SIBP04, Zirabev

Treatment (AB-complex)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (AB-complex)

Nab-paclitaxel DRUG

Given IV

Also known as: ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Protein-bound Paclitaxel

Treatment (AB-complex)

Pharmacological Study OTHER

Correlative studies

Treatment (AB-complex)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years
• Melanoma cohort only: histologic proof of surgically unresectable stage IV malignant melanoma
• Melanoma cohort only: 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 \>= 1.0 cm with computed tomography (CT) scan or magnetic resonance imaging (MRI) scan; or CT component of a positron emission tomography (PET)/CT; NOTE: disease that is measurable by physical examination only is not eligible
• Gynecologic cancer cohorts only (dose escalation and dose expansion cohorts)
• Dose escalation 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
• Endometrial cancer expansion cohort only:
• Histologic proof of endometrial cancer including endometrioid, serous, clear cell, mucinous, undifferentiated, mixed, and carcinosarcoma histologies
• lines of cytotoxic or immune checkpoint inhibitor therapy (not including hormonal therapy or other regimens not containing cytotoxic agents or immune checkpoint inhibitors)
• If one (1) prior line of therapy, must have contained a taxane, a platinum drug, and and immune checkpoint inhibitor
• If 2-3 prior lines of therapy, at least one must have contained a taxane and a platinum drug, and at least one must have contained an immune checkpoint inhibitor
• Ovarian cancer expansion cohort only:
• Histologic proof of ovarian cancer including high grade serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, mixed, and carcinosarcoma histologies
• lines of cytotoxic chemotherapy (not including hormonal therapy or other non-cytotoxic regimens)
• At least one prior line of chemotherapy must have contained a taxane and a platinum agent
• If 1 or 2 prior lines of chemotherapy, patient's disease must be platinum-resistant

You may not qualify if:

• 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 =\< 28 days prior to registration
• No more than 3 systemic therapies (cytotoxic or immunologic) =\< 2 years prior to registration
• Melanoma cohort only: Treatment with ipilimumab =\< 6 months prior to registration.
• Intravenous anti-cancer therapy or investigational agents =\< 4 weeks prior to registration or non-intravenous anti-cancer therapy or investigational agents =\< 2 weeks prior to registration
• Note: No washout period is required for hormone-based therapies
• Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring systemic treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations (e.g., drug addiction) that would limit compliance with study requirements
• Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
• History or indication of brain metastases per MRI or CT at any time prior to registration
• NOTE: Patients who 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 persons
• Nursing persons
• Persons 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (4)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Bevacizumab; Immunoglobulin G; Disulfides; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Taxes

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Isotypes; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Economics; Health Care Economics and Organizations

Study Officials

• Matthew S. Block, M.D., Ph.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: December 25, 2013
• Study Start: February 24, 2014
• Primary Completion: July 18, 2024
• Study Completion: July 18, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

US (4)