A research study to compare different chemotherapy treatment options for recurrent ovarian cancer.

Phase II randomized study evaluating pemetrexed plus carboplatin versus pegylated liposomal doxorubicin plus carboplatin as second-line therapy in platinum-sensitive recurrent ovarian, fallopian tube, or primary peritoneal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100309

Enrollment

130

Registered

2026-01-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: C51-C58- Malignant neoplasms of female genital organs Health Condition 2: C51-C58- Malignant neoplasms of female genital organs Health Condition 3: C51-C58- Malignant neoplasms of female genital organs Health Condition 4: C51-C58- Malignant neoplasms of female genital organs Health Condition 5: C51-C58- Malignant neoplasms of female genital organs Health Condition 6: C51-C58- Malignant neoplasms of female genital organs Health Condition 7: C51-C58- Malignant neoplasms of fema

Interventions

Intervention1: Carboplatin with Pemetrexed: Arm A (Experimental) Pemetrexed 500 mg/m IV + Carboplatin AUC 5 IV every 3 weeks up to 6 cycles Followed by pemetrexed maintenance every 3 weeks until d

Eligibility

Inclusion criteria

Inclusion criteria: Woman more than 18 years old with Performance status 0 to 2 2. Patients previously treated for biopsy-proven epithelial ovarian cancer primary peritoneal cancer or fallopian tube cancer with surgery and platinum-based chemotherapy. Radiological evidence of disease recurrence occurring at least six months after completion of the last cycle of platinum based chemotherapy 3. Written informed consent obtained from subject or subject s legal representative and ability for subject to comply with the requirements of the study

Exclusion criteria

Exclusion criteria: Prior history of radiotherapy which may affect patient tolerability to chemotherapy 2. Patients with congestive heart failure symptomatic NYHA class>=III 3. Pre-treatment documented LV dysfunction and/or ejection fraction <50% 4. Estimated creatinine clearance <45ml/min Institutional Review Board application form (INTERVENTIONAL), Version 3.4, July 2024 Page 23 5. Patients unable to be regularly followed for any reason (geographic, familial, social, psychologic). 6. Any mental or physical handicap at risk of interfering with the appropriate treatment. 7. Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer. 8. Mucinous Ovarian Carcinoma 9. Acute intestinal obstruction Method of randomization: Randomization will be performed by minimization

Design outcomes

Primary

Measure	Time frame
one year progression-free survival (PFS)Timepoint: 12 months from Randomisation	—

Secondary

Measure	Time frame
overall survival Quality of Life Safety & TolerabilityTimepoint: OS-Analysed at end of study QOL-Baseline,6 weeks,12 weeks & every 3 months Safety & tolerability will be asessed throughout the study	—

Countries

India

Contacts

Public ContactSusmitha Venkitaswamy

CHRISTIAN MEDICAL COLLEGE

susmit69@gmail.com9080121899

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026