Combination oral chemotherapy in advanced ovarian cancer

Pazopanib based combination oral metronomic therapy in platinum resistant, platinum refractory and advanced ovarian cancer : A Randomized Phase 2 Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/10/010219

Enrollment

Registered

2017-10-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Platinum Resistant, Platinum Refractory And Advanced Ovarian Cancer

Interventions

Intervention1: Arm B: Arm B will receive Pazopanib (dose 400 mg OD Daily ) alongwith tab VP-16 (dose 50 mg OD day 1 to Day 14) and tablet Cyclophosphamide (dose 50 mg D1 to D21) Control Intervention

Eligibility

Inclusion criteria

Inclusion criteria: a.Written Informed consent by all study participants b.Female subjects > 18 years of age with histologically confirmed diagnosis of epithelial ovarian cancer which is platinum resistant, platinum refractory, Or advanced (Prior treatment with at least 2 chemotherapy regimens in advanced tumor setting). c. Patients must have failed available standard chemotherapy regimen (except if medically contraindicated or refused by the patient) d. Performance status ECOG 0-2 e. Adequate organ functions i. Adequate bone marrow function (e.g. platelets > 100 x 109/L, ANC > 1.5 x 109/LHb >10gm%) ii. Adequate liver function (e.g. ALT/AST iii. Adequate renal function (e.g. creatinine clearance > 50 ml/min) iv. Adequate cardiac function (e.g. LVEF >40%) f. Able to swallow and retain oral medication g. A life expectancy of at least 12 weeks

Exclusion criteria

Exclusion criteria: a.Age b.Patients not willing to consent for the study c.ECOG Performance status 3 and 4 d.Active infection (pneumonia etc.)History of Uncontrolled hypertension ,ischemic event or clinical evidence of thrombo-embolic event e.History of haemoptysis, cerebral, or clinically significant gastrointestinal haemorrhage in the past 6months f.Clinically significant gastrointestinal abnormalities which might interfere with oral dosing g.Any other organ dysfunction (CTCAE Grade 4)

Design outcomes

Primary

Measure	Time frame
To assess the Serological Progression free survival (PFS)Timepoint: at 3 months and 6 months	—

Secondary

Measure	Time frame
To assess (Quality of Life)QOLTimepoint: at Baseline , 3 months and 6 months;To assess angiogenic marker expression and effect of drugTimepoint: At baseline, 3 months and 6 months;To assess Serological Response Rates (Rustin criteria ) :Proportion of women in partial, compete or stable diseaseTimepoint: At 3 months and 6 months from start of therapy;To assess the Toxicity of the agents using CTCAE 4.0Timepoint: at 3 months and 6 months from start of therapy	—

Measure

Time frame

To assess (Quality of Life)QOLTimepoint: at Baseline , 3 months and 6 months;To assess angiogenic marker expression and effect of drugTimepoint: At baseline, 3 months and 6 months;To assess Serological Response Rates (Rustin criteria ) :Proportion of women in partial, compete or stable diseaseTimepoint: At 3 months and 6 months from start of therapy;To assess the Toxicity of the agents using CTCAE 4.0Timepoint: at 3 months and 6 months from start of therapy

—

Countries

India

Contacts

Public ContactAparna Sharma

ALL INDIA INSTITUE OF HEALTH SCIENCES

lalitaiims@yahoo.com7895683095

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 22, 2026