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

• ClinicalTrials.gov Identifier: NCT02429687
• Recruitment Status: Recruiting
• First Posted: April 29, 2015
• Last Update Posted: July 22, 2020
• Sponsor: Beihua Kong
• Collaborators: Huazhong University of Science and Technology; Zhejiang University; Sun Yat-sen University
• Information provided by (Responsible Party): Beihua Kong, Shandong University

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Locations

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

• Principal Investigator: Beihua Kong; Qilu Hospital of Shandong University

More Information

• Responsible Party: Beihua Kong, MD. PhD., Shandong University
• ClinicalTrials.gov Identifier: NCT02429687
• Other Study ID Numbers: MOGCT-01
• First Posted: April 29, 2015
• Last Update Posted: July 22, 2020
• Last Verified: July 2020

Additional relevant MeSH terms:

Ovarian Neoplasms; Neoplasms, Germ Cell and Embryonal; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Neoplasms by Histologic Type; Paclitaxel; Etoposide; Carboplatin; 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