Belotecan Versus Topotecan for Recurrent Ovarian Cancer: A Randomized, Open-label, Parallel-group Phase IIb Trial

Chong Kun Dang

Status and phase: Completed; Phase 2

Conditions: Epithelial Ovarian Cancer

Treatments: Drug: Belotecan; Drug: Topotecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01630018

11AOC09J

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and safety of belotecan or topotecan in patients with recurrent or refractory ovarian cancer (AOC).

Full description

A Phase Ⅱb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan (CamtoBell inj.) or Topotecan in Patients with Recurrent or Refractory Ovarian Cancer

Enrollment: 141 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age

• Histological or cytological diagnosis of AOC

• Stable disease (SD) or progression at time of study entry Recurrent or progressive AOC ≥ 90 days of duration of response for first-line therapy

• Measurable disease defined by RECIST criteria

• ECOG Performance Status of 0, 1, or 2

• Life expectancy > 3 months

• Adequate bone marrow, Renal, Hepatic reserve:

  • absolute neutrophil (segmented and bands) count (ANC) ≥ 1500 cells/μL
  • platelet count ≥ 100,000 cells/μL
  • hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 1.5 X ULN
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 X ULN
  • Alkaline Phosphatase (ALP) ≤ 2.0 X ULN
  • Serum creatinine < 1.5mg/dL or calculated creatinine clearance > 60mL/min

• Signed a written informed consent

Exclusion criteria

• Active infection
• Symptomatic brain lesion
• Any other type of cancer during the previous 5 years except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix Severe concurrent diseases
• Prior anticancer therapy within 4 weeks before enroll
• Active pregnancy test and Pregnant or nursing women
• Participation in any investigational drug study within 28 days prior to study entry

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 2 patient groups

Topotecan

Active Comparator group

Description:

Topotecan

Treatment:

Drug: Topotecan

Camtobell

Active Comparator group

Description:

Belotecan

Treatment:

Drug: Belotecan