CTRI/2025/12/098858Not yet recruitingPhase 2
Efficacy and safety of Carboplatin with Pemetrexed or Paclitaxel for frail women with advanced ovarian, peritoneal, or fallopian tube cancer: an open-label, randomized, phase 2 trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- CMC
- Enrollment
- 102
- Locations
- 1
Study Overview
Brief Summary
Epithelial ovarian cancer is the third most common cancer in Indian women, with high mortality. Frail patients experience excessive toxicity from standard carboplatin-paclitaxel, while single-agent carboplatin yields inferior outcomes. Pemetrexed, with its favorable safety profile and efficacy in relapsed disease, may offer a better-tolerated alternative. This trial evaluates whether carboplatin-pemetrexed improves tolerability without compromising efficacy compared to standard therapy in frail patients (Frailty Index more than or equal to 0.15).This study tests whether a gentler chemotherapy combo (carboplatin-pemetrexed) works as well as standard treatment but with fewer side effects in frail ovarian cancer patients. If successful, it could offer a safer option for frail women.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Woman more than or equal to 18 years old
- •Histologically or cytologically proven FIGO stage III to IV epithelial ovarian cancer or peritoneal primary or fallopian tube. A cytological proof is accepted if associated with a ratio of CA125 divided by CEA more than 25 and pelvic mass in radiological imaging
- •Frail patients according to Frailty Deficit Index (FI) score.
- •frailty is defined as an FI more than or equal to 0.15
- •Written informed consent obtained from subject or subject’s legal representative and ability for subject to comply with the requirements of the study
- •Required initial laboratory parameters: a. Absolute Neutrophil Count more than or equal to 1,000/mm3 b. Hemoglobin greater than 10.0 g/dL c. Platelets more than or equal to 100,000/mm3 d. Total Bilirubin less than 1.5x ULN (Upper Limit of Normal) e. Serum ALT less than 2.5 x ULN f. Estimated creatinine clearance more than 60 ml/min(MDRD equation or Cockcroft Gault formula) g. PT/INR less than 1.5 x ULN.
Exclusion Criteria
- •FIGO Stage I or II
- •Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study 3.Major surgical procedure within 28 days prior to randomization or anticipation of need for major surgery during the course of study, other than that required for the ovarian cancer treatment itself
- •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
- •Prior history of chemotherapy for the present malignancy
- •Prior history of radiotherapy which may affect patient tolerability to chemotherapy
- •Documented baseline neuropathy CTCAE v5.0 grade greater than or equal to 2
- •Patients with congestive heart failure symptomatic NYHA class greater than or equal to III
- •Pre-treatment documented LV dysfunction and/or ejection fraction less than 50%
- •Estimated creatinine clearance less than 60ml/min
- •Patients unable to be regularly followed for any reason (geographic, familial, social, psychologic) 11.
Investigators
Ashish Singh
Christian Medical College, Vellore
Study Sites (1)
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