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

Beihua Kong

Status and phase: Enrolling; Phase 3

Conditions: Ovarian Neoplasms; Ovarian Cancer; Ovarian Germ Cell Cancer

Treatments: Drug: Carboplatin; Drug: Paclitaxel; Drug: Cisplatin; Drug: Bleomycin; Drug: Etoposide

Study type: Interventional

Funder types: Other

Identifiers

NCT02429687

MOGCT-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 estimated patients

Sex: Female

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 2 patient groups

PT (Arm 1)

Experimental group

Description:

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.

Treatment:

Drug: Carboplatin

Drug: Paclitaxel

BEP (Arm 2)

Active Comparator group

Description:

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.

Treatment:

Drug: Etoposide

Drug: Bleomycin

Drug: Cisplatin