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Bevacizumab Combined With Carboplatin Plus Paclitaxel Chemotherapy to Treat Metastatic Mucosal Melanoma

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ClinicalTrials.gov Identifier: NCT02023710
Recruitment Status : Unknown
Verified May 2017 by Jun Guo, Peking University Cancer Hospital & Institute.
Recruitment status was:  Recruiting
First Posted : December 30, 2013
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Jun Guo, Peking University Cancer Hospital & Institute

Study Description
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Brief Summary:
Mucosal melanoma is rare and associated with extremely poor prognosis.No effective treatment for advanced mucosal melanoma patients.Investigators conducted a randomized phase II study in patients with previously untreated metastatic mucosal melanoma to characterize the efficacy and safety of bevacizumab when combined with carboplatin plus paclitaxel.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Paclitaxel Drug: Carboplatin Drug: Bevacizumab Phase 2

Detailed Description:
Mucosal melanoma is rare and associated with extremely poor prognosis.It is the second most common subtype in Asians.No effective treatment for advanced mucosal melanoma patients.Malignant melanoma is a highly vascular tumor in which vascular endothelial growth factor(VEGF) is strongly expressed and seems to play an important role in disease progression.A randomized phase II study evaluated the activity of Bevacizumab in combination with carboplatin plus paclitaxel(CPB arm) in patients with previously untreated advanced melanoma.Overall response rates was 25.5%,median overall survival time(OS) was 12.3 months in the CPB arm. Investigators conducted a randomized phase II study in patients with previously untreated metastatic mucosal melanoma to characterize the efficacy and safety of bevacizumab when combined with carboplatin plus paclitaxel.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study Evaluating the Activity of Bevacizumab in Combination With Carboplatin Plus Paclitaxel in Patients With Previously Untreated Advanced Mucosal Melanoma
Study Start Date : December 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: BEV plus Chemotherapy
Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; Bevacizumab 5mg/kg, d1、15; 28 days a cycle
 Drug: Paclitaxel
175 mg/m^2 by IV infusion on the first day of each 4-week cycle (dose was based on patient's weight and could be adjusted for weight change)
Other Name: Taxel

Drug: Carboplatin
Dose based on patients' creatinine clearance (Calvert formula) and administered by intravenous (IV) infusion on the first day of each 4-week cycle
Other Name: CBP

Drug: Bevacizumab
5mg/kg by intravenous (IV) infusion every two weeks of each 4-week cycle (dose was based on patient's weight at screening and remained the same throughout study)
Other Name: BEV
Active Comparator: Chemotherapy alone
Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; 28 days a cycle
 Drug: Paclitaxel
175 mg/m^2 by IV infusion on the first day of each 4-week cycle (dose was based on patient's weight and could be adjusted for weight change)
Other Name: Taxel

Drug: Carboplatin
Dose based on patients' creatinine clearance (Calvert formula) and administered by intravenous (IV) infusion on the first day of each 4-week cycle
Other Name: CBP


Outcome Measures
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Primary Outcome Measures :
  1. progress-free survival(PFS) [ Time Frame: From randomization up to 144 weeks ]
    Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause.


Secondary Outcome Measures :
  1. adverse event(AE) [ Time Frame: From randomization up to144 weeks ]
    Any events,no matter related to interventions,occur during the period from the enrollment to death or 30 days after withdrawal from the trial

  2. Overall Survival(OS) [ Time Frame: Up to 144 weeks ]
    Overall survival was defined as the time from randomization to death from any cause.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed mucosal melanoma with metastases and has no received any systemic treatment.
  2. ECOG performance status 0, 1
  3. Estimated life expectancy of 12 weeks or greater
  4. Age 18 years or older, male or female
  5. At least one measurable site (diameter≥1cm) of disease (RECIST 1.1).
  6. Adequate organ function
  7. Without symptoms of brain metastases and stable in neuro-functions.
  8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria:

  1. Mutations in C-KIT or BRAF-V600E, asked for other target treatments
  2. Pregnant or lactation women
  3. Acute infections without control.
  4. Heart disease history, cardiac function class≥NYHA II.
  5. HIV positive or chronic HBV/HCV in active stage.
  6. Brain metastases or primary tumor with positive symptoms
  7. Need anti-epileptic treatments
  8. Organ transplantation history
  9. Hemorrhagic tendency or related history
  10. Renal dialysis patients
  11. Diagnosis of any second malignancy within the last 3 years, except for adequately treated.
  12. Current treatment on another clinical trial
  13. The other improper situations which investigator judged.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02023710


Contacts
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Contact: Xinan Sheng, MD 0086-10-88196951 doctor_sheng@126.com

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Xiaoshi Zhang, MD    0086-20-87343088    zxs617@hotmail.com   
Principal Investigator: Xiaoshi Zhang, MD         
China
Beijing Cancer Hospital Recruiting
Beijing, China, 100142
Contact: Xinan Sheng, MD    0086-10-88196951    doctor_sheng@126.com   
Principal Investigator: Jun Guo, MD         
Yunan Tumor Hospital Recruiting
Kunming, China, 650106
Contact: Xin Song, MD    0086-871-8185656    songxin68@126.com   
Principal Investigator: Xin Song, MD         
Sponsors and Collaborators
Peking University Cancer Hospital & Institute
Investigators
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Principal Investigator: Jun Guo, MD Peking University Cancer Hospital & Institute
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jun Guo, Director of department of renal cancer and melanoma, Peking University Cancer Hospital & Institute
ClinicalTrials.gov Identifier: NCT02023710    
Other Study ID Numbers: BCH-MM-131101
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Keywords provided by Jun Guo, Peking University Cancer Hospital & Institute:
mucosal melanoma
Bevacizumab
Carboplatin
Paclitaxel
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
 Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors