A new medicine for cancer of the ovary which has returned after initial treatment

Phase 2

Completed

• Conditions: Health Condition 1: C00-D49- Neoplasms

• Registration Number: CTRI/2020/06/025790
• Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education and Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 59

Inclusion Criteria

1. Platinum-sensitive-relapsed-(serous-epithelial)-ovarian cancer planned for salvage chemotherapy with paclitaxel and carboplatin.

2. Measurable disease (elevated CA-125 or measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria) at the time of study enrolment.

3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

4. Acceptable bone marrow and organ function at screening as described below:

a. ANC greater or equal to 1500/µL (without WBC growth factor support)

b. Platelet count greater or equal to 75,000/µL;

c. Haemoglobin greater or equal to 8 g/dL

d. Total Bilirubin less than or equal to 1.5 mg/dl;

e. AST (SGOT) less than or equal to 3 x ULN (as per JIPMER biochemistry) (less than or equal to 5 × ULN if known liver metastases)

f. ALT (SGPT) less than or equal to 3 x ULN (as per JIPMER biochemistry) (less than or equal to (less than or equal to 5 × ULN if known liver metastases)

g. Serum creatinine less than 2 mg/dL or a measured creatinine clearance greater than or equal to 50 mL/min according to Cockcroft-Gault formula

5. Patients willing to give informed consent and comply with study procedures.

Exclusion Criteria

1. Patients with Pre-existing retinal disease.

2. Patients on Long term therapy with hydroxychloroquine.

3. Prolonged corrected QTc interval in ECG >480ms.

4. Patients planned for cytoreductive surgery at the time of relapse.

5. Patients planned for bevacizumab or PARP inhibitor.

6. Patients with serious intercurrent illnesses that will preclude the administration of protocol treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response RatesTimepoint: After 3 cycles of chemotherapy

Secondary Outcome Measures

Name	Time	Method
Overall SurvivalTimepoint: 3 years.;Progression Free SurvivalTimepoint: Time from randomization till demonstration of disease progression.;Quantification of Biomarkers.Timepoint: Baseline and after 3 cycles.