TC or BEP in Treating Patients With Malignant Ovarian Germ Cell Tumors

NCT ID: NCT02429687

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2030-05-31

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.

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.

Conditions

Ovarian Germ Cell Cancer; Ovarian Neoplasms; Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

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.

Carboplatin

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Bleomycin

Intervention Type: DRUG

Bleomycin 30000IU IM per day for 3 days every 3 weeks for 3-4 cycles.

Etoposide

Intervention Type: DRUG

Etoposide 100mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles.

Cisplatin

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Bleomycin

Bleomycin 30000IU IM per day for 3 days every 3 weeks for 3-4 cycles.

Intervention Type: DRUG

Etoposide

Etoposide 100mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Anzatax; TAX; Blanoxan; BLEO; BLM; ETOP; Etopophos

Eligibility 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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Beihua Kong

OTHER

Sponsor Role: lead

Responsible Party

Beihua Kong

MD. PhD.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Beihua Kong

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Beihua Kong, MD. PhD.

Role: CONTACT

kongbeihua@sdu.edu.cn

+8618560081888

Facility Contacts

Beihua Kong, MD. PhD.

Role: primary

kongbeihua@sdu.edu.cn

+8618560081888

Other Identifiers

MOGCT-01

Identifier Type: -

Identifier Source: org_study_id