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Trial record 12 of 57 for:    "Germ Cells Tumors" | "Carboplatin"

TC or BEP in Treating Patients With Malignant Ovarian Germ Cell Tumors (MOGCT-01)

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ClinicalTrials.gov Identifier: NCT02429687
Recruitment Status : Recruiting
First Posted : April 29, 2015
Last Update Posted : March 22, 2019
Sponsor:
Collaborators:
Huazhong University of Science and Technology
Zhejiang University
Sun Yat-sen University
Information provided by (Responsible Party):
Beihua Kong, Shandong University

Brief Summary:
Investigators will conduct the trial to determine whether paclitaxel and cisplatin (PT) has the same curative effects and less adverse effects than bleomycin, etoposide and cisplatin(BEP) among newly diagnosed malignant ovarian germ cell tumor patients after surgery.

Condition or disease Intervention/treatment Phase
Ovarian Germ Cell Cancer Ovarian Neoplasms Ovarian Cancer Drug: Paclitaxel Drug: Carboplatin Drug: Bleomycin Drug: Etoposide Drug: Cisplatin Phase 3

Detailed Description:

PRIMARY OBJECTIVES:

To assess the activity of paclitaxel and carboplatin with respect to progression free survival (using bleomycin, etoposide, and cisplatin [BEP] as a reference) for newly diagnosed malignant ovarian germ cell tumors.

SECONDARY OBJECTIVES:

  1. To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide, and cisplatin in this patient population.
  2. To estimate overall survival for paclitaxel and carboplatin relative to that of BEP.
  3. To evaluate response rate in the subset of patients with measurable disease. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

ARM 1: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients receive bleomycin IM daily for days 1-3, etoposide IV daily for days 1-5, cisplatin IV for days 1-5. Treatment repeats every 21 days for 3 or 4* courses in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients who have good risk will have 3 courses and those who have poor risks will have 4 courses.

Patients undergo blood sample collection at baseline and periodically during study for laboratory biomarker analysis.

After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized Trial Comparing Paclitaxel and Carboplatin or Bleomycin, Etoposide and Cisplatin in the Treatment of Malignant Ovarian Germ Cell Tumors
Study Start Date : April 2015
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2024


Arm Intervention/treatment
Experimental: PT (Arm 1)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
Drug: Paclitaxel
Patients receive paclitaxel 175mg/㎡ IV over 3 hours on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
Other Names:
  • Anzatax
  • TAX

Drug: Carboplatin
and carboplatin AUC 5-6 IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.

Active Comparator: BEP (Arm 2)

Patients receive bleomycin IM daily for days 1-3, etoposide IV daily for days 1-5, cisplatin IV for days 1-5. Treatment repeats every 21 days for 3 or 4* courses in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients who have good risk will have 3 courses and those who have poor risks will have 4 courses.

Drug: Bleomycin
Bleomycin 30000IU IM per day for 3 days every 3 weeks for 3-4 cycles.
Other Names:
  • Blanoxan
  • BLEO
  • BLM

Drug: Etoposide
Etoposide 100mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles.
Other Names:
  • ETOP
  • Etopophos

Drug: Cisplatin
Cisplatin 20mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity.




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Date of randomization, and death due to any cause, assessed up to 5 years ]
    PFS was definite as the time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence.


Secondary Outcome Measures :
  1. Chemotherapy related adverse effects in two arms [ Time Frame: Up to 5 years ]
  2. Tumor response rate [ Time Frame: Up to 5 years ]
    The relationship of treatment to tumor response rate will be assessed using logistic regression models adjusted for age and stratification factor (measurable disease status).

  3. Overall survival [ Time Frame: Up to 5 years ]
    The relationship of treatment to overall survival will be assessed using the proportional hazards model.



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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age≤65 years; female, Chinese women;
  • Histologically confirmed ovarian stromal tumor, including the following cell types:

    • Granulosa cell tumor
    • Granulosa cell-theca cell tumor
    • Sertoli-Leydig cell tumor (androblastoma)
    • Steroid (lipid) cell tumor
    • Gynandroblastoma
    • Unclassified sex cord-stromal tumor
    • Sex cord tumor with annular tubules
  • Newly diagnosed, stage IIA-IVB disease;

    • Has undergone initial surgery (for diagnosis, staging, or cytoreduction) within the past 8 weeks.
    • May or may not have measurable residual disease.
  • Laboratory tests: WBC≥4×10(9)/L, NEU≥2×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Cr≤ normal
  • Performance status: Karnofsky score≥60;
  • Provide written informed consent.

Exclusion Criteria:

  • With severe or uncontrolled internal disease, unable to receive surgery and/or unsuitable for chemotherapy;
  • History of organ transplantation, immune diseases;
  • History of serious mental illness, a history of brain dysfunction;
  • Drug abuse or a history of drug abuse;
  • Suffering from other malignancies;
  • Concurrently participating in other clinical trials
  • Unable or unwilling to sign informed consents;
  • Unable or unwilling to abide by protocol.

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): NCT02429687


Contacts
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Contact: Beihua Kong, MD. PhD. +8618560081888 kongbeihua@sdu.edu.cn

Locations
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China, Shandong
Qilu Hospital of Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Beihua Kong, MD. PhD.    +8618560081888    kongbeihua@sdu.edu.cn   
Sponsors and Collaborators
Beihua Kong
Huazhong University of Science and Technology
Zhejiang University
Sun Yat-sen University
Investigators
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Principal Investigator: Beihua Kong Qilu Hospital of Shandong University

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Responsible Party: Beihua Kong, MD. PhD., Shandong University
ClinicalTrials.gov Identifier: NCT02429687     History of Changes
Other Study ID Numbers: MOGCT-01
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Carboplatin
Ovarian Neoplasms
Neoplasms, Germ Cell and Embryonal
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Paclitaxel
Etoposide
Albumin-Bound Paclitaxel
Cisplatin
Etoposide phosphate
Bleomycin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antibiotics, Antineoplastic