Low dose oral metronomic therapy in recurrent refractory uterine endometrial cancer

Low dose Oral Metronomic Cyclophosphamide and Etoposide combination in Recurrent/Refractory High Grade Endometrial Cancer, a Single Arm Phase 2 Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070458

Enrollment

Registered

2024-07-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Health Condition 1: C55- Malignant neoplasm of uterus, partunspecified

Interventions

Intervention1: ORAL CYCLOPHOSPHAMIDE AND ORAL ETOPOSIDE: Oral Cyclophosphamide 50mg/d D1-D21 q28d and Oral etoposide 50mg/d D1-D14 q28d in form of oral metronomic therapy to the patients with recurren

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed recurrent / refractory high grade endometrial cancer [endometroid/serous/carcinosarcoma/clear cell] 2. One or more prior lines of therapy with at least one platinum based chemotherapeutic regimen, containing carboplatin or cisplatin with platinum free interval of less than 1 year. 3. Written informed consent. 4. ECOG PS 0-2 5. Measurable disease with at least one target lesion which could be used for response evaluation as per RECIST 1.1 criteria 6. Adequate organ function

Exclusion criteria

Exclusion criteria: 1. Low grade [grade I/II] endometrial cancer 2. Patient who are eligible for hormonal therapy 3. Patients with recurrent carcinoma endometrium with platinum free interval of more than 1 year 4. Chemotherapy naïve patient [adjuvant/metastatic setting] 5. Patients who are eligible/affordable for immunotherapy

Design outcomes

Primary

Measure	Time frame
To assess disease control rate [Clinical benifit rate ; complete responce + Partial Responce + stable disease] in recurrent high grade endometrial cancer with oral metronomic therapy with cyclophosphamide and etoposide.Timepoint: Response assessment will be done after 3 cycles of cyclophosphamide and etoposide OMT using clinico-radiological (CECT) and biochemical assessment (if CA-125 and CA19.9 levels elevated at baseline). Subsequently every 3 months response assessment will be done or earlier if apparent progressive disease.	—

Measure

Time frame

To assess disease control rate [Clinical benifit rate ; complete responce + Partial Responce + stable disease] in recurrent high grade endometrial cancer with oral metronomic therapy with cyclophosphamide and etoposide.Timepoint: Response assessment will be done after 3 cycles of cyclophosphamide and etoposide OMT using clinico-radiological (CECT) and biochemical assessment (if CA-125 and CA19.9 levels elevated at baseline). Subsequently every 3 months response assessment will be done or earlier if apparent progressive disease.

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Secondary

Measure	Time frame
1. To assess the Objective Response Rate [ORR; Complete Response (CR) + Partial Response (PR)] [RECIST v1.1] the in recurrent high grade endometrial cancer with oral metronomic therapy with cyclophosphamide & etoposide. 2. To assess the Clinical Benefit Rate (CBR) will be defined as the percentage of patients who will achieve complete response, partial response, or at least six months of stable disease as a result of therapy. 3. To assess the Progression Free Survival (PFS) & Overall Survival (OS) censored at the end of study period. 4. To evaluate the change in Quality of Life (QOL) at different time points 5. To assess the treatment related adverse events using CTCAE v5.0. Timepoint: Response assessment will be done after 3 cycles of cyclophosphamide & etoposide OMT using clinicoradiological (CECT) & biochemical assessment, if CA-125 & CA19.9 levels elevated at baseline. Subsequently every 3 months response assessment will be done or earlier if apparent progressive disease.	—

Measure

Time frame

1. To assess the Objective Response Rate [ORR; Complete Response (CR) + Partial Response (PR)] [RECIST v1.1] the in recurrent high grade endometrial cancer with oral metronomic therapy with cyclophosphamide & etoposide. 2. To assess the Clinical Benefit Rate (CBR) will be defined as the percentage of patients who will achieve complete response, partial response, or at least six months of stable disease as a result of therapy. 3. To assess the Progression Free Survival (PFS) & Overall Survival (OS) censored at the end of study period. 4. To evaluate the change in Quality of Life (QOL) at different time points 5. To assess the treatment related adverse events using CTCAE v5.0. Timepoint: Response assessment will be done after 3 cycles of cyclophosphamide & etoposide OMT using clinicoradiological (CECT) & biochemical assessment, if CA-125 & CA19.9 levels elevated at baseline. Subsequently every 3 months response assessment will be done or earlier if apparent progressive disease.

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Countries

India

Contacts

Public ContactDr Bhoor Singh

AIIMS NEW DELHI

dr.sachinkhurana@gmail.com9769030180

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026