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AzTrials

MelanomaPhase 2NCT02023710

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

A Phase 2 study testing Paclitaxel, Carboplatin and Bevacizumab in people with Melanoma, run by Peking University Cancer Hospital & Institute at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Melanoma
What is being tested?
Paclitaxel, Carboplatin and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
3 sitesChina
Study dates
Dec 2013to Dec 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Mutations in C-KIT or BRAF-V600E, asked for other target treatments
  • Pregnant or lactation women
  • Acute infections without control.
  • Heart disease history, cardiac function class≥NYHA II.
  • HIV positive or chronic HBV/HCV in active stage.
  • Brain metastases or primary tumor with positive symptoms
Show all 13Show fewer
  • Need anti-epileptic treatments
  • Organ transplantation history
  • Hemorrhagic tendency or related history
  • Renal dialysis patients
  • Diagnosis of any second malignancy within the last 3 years, except for adequately treated.
  • Current treatment on another clinical trial
  • The other improper situations which investigator judged.

Trial locations and contacts

3 sites in 1 country.

Xinan Sheng, MD contact

0086-10-88196951

doctor_sheng@126.com

China3 sites, 3 recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

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

    Jun Guo, MD

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Xiaoshi Zhang, MD, 0086-20-87343088, zxs617@hotmail.com

    Xiaoshi Zhang, MD

    Recruiting

  • Yunan Tumor Hospital

    Kunming, 650106

    Xin Song, MD, 0086-871-8185656, songxin68@126.com

    Xin Song, MD

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Melanoma
Keywords
mucosal melanoma, Bevacizumab, Carboplatin, Paclitaxel
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called Taxel

    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)

  • CarboplatinDrug

    Also called CBP

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

  • BevacizumabDrug

    Also called BEV

    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)

Study groups in NCT02023710
Study groupRoleWhat they receive
BEV plus ChemotherapyExperimentalPaclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; Bevacizumab 5mg/kg, d1、15; 28 days a cycle
Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Bevacizumab
Chemotherapy aloneActive comparatorPaclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; 28 days a cycle
Receives: Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progress-free survival(PFS)

    Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause.

    Measured: From randomization up to 144 weeks

Secondary outcomes (2)

  1. adverse event(AE)

    Any events,no matter related to interventions,occur during the period from the enrollment to death or 30 days after withdrawal from the trial

    Measured: From randomization up to144 weeks

  2. Overall Survival(OS)

    Overall survival was defined as the time from randomization to death from any cause.

    Measured: Up to 144 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
182 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02023710
Sponsor's protocol ID
BCH-MM-131101
Status last verified
May 2017
First submitted
19 Dec 2013
Last updated
9 May 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Kim KB, Sosman JA, Fruehauf JP, Linette GP, Markovic SN, McDermott DF, Weber JS, Nguyen H, Cheverton P, Chen D, Peterson AC, Carson WE 3rd, O'Day SJ. BEAM: a randomized phase II study evaluating the activity of bevacizumab in combination with carboplatin plus paclitaxel in patients with previously untreated advanced melanoma. J Clin Oncol. 2012 Jan 1;30(1):34-41. doi: 10.1200/JCO.2011.34.6270. Epub 2011 Nov 28.

    PubMed 22124101

  • Chi Z, Li S, Sheng X, Si L, Cui C, Han M, Guo J. Clinical presentation, histology, and prognoses of malignant melanoma in ethnic Chinese: a study of 522 consecutive cases. BMC Cancer. 2011 Feb 25;11:85. doi: 10.1186/1471-2407-11-85.

    PubMed 21349197

  • Lian B, Si L, Cui C, Chi Z, Sheng X, Mao L, Li S, Kong Y, Tang B, Guo J. Phase II randomized trial comparing high-dose IFN-alpha2b with temozolomide plus cisplatin as systemic adjuvant therapy for resected mucosal melanoma. Clin Cancer Res. 2013 Aug 15;19(16):4488-98. doi: 10.1158/1078-0432.CCR-13-0739. Epub 2013 Jul 5.

    PubMed 23833309

  • Yan X, Sheng X, Chi Z, Si L, Cui C, Kong Y, Tang B, Mao L, Wang X, Lian B, Li S, Bai X, Zhou L, Dai J, Yao H, Guo J. Randomized Phase II Study of Bevacizumab in Combination With Carboplatin Plus Paclitaxel in Patients With Previously Untreated Advanced Mucosal Melanoma. J Clin Oncol. 2021 Mar 10;39(8):881-889. doi: 10.1200/JCO.20.00902. Epub 2021 Jan 14.

    PubMed 33444116

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Carboplatin and Bevacizumab in people with Melanoma, run by Peking University Cancer Hospital & Institute at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xinan Sheng, MD (0086-10-88196951, doctor_sheng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progress-free survival(PFS) (time frame: From randomization up to 144 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02023710, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.

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