Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: Tablet Capecitabine: 625 mg/m2 twice daily Per Oral, until progressive disease or unacceptable toxicity in combination with Inj. Bevacizumab 7.5 mg/kg i.v. q 21 days until Progressive d
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 Years and older, has persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not progressed on platinum based palliative chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation). The last chemotherapy cycle should have been administered at least 2 weeks before randomization with resolution of all treatment -related toxicities. Adverse effects due to previous chemotherapy should be resolved to = Grade 1 or baseline. Participants with = Grade 2 neuropathy or = Grade 2 alopecia are eligible. 2. Not pregnant or breastfeeding, and a woman of child-bearing potential (WOCBP ) must agree to use effective contraception during the treatment period. 3.Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology 4. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 5. Has adequate organ function 6. Participants with known brain metastases may participate, provided that the brain metastases have been previously treated and are radiographically stable. 7. HIV-positive patients are allowed if on HAART with HIV status controlled on treatment. 8. Palliative radiotherapy/palliative surgical interventions are allowed. 9. Mentally competent and literate to be able to provide informed consent. 10. Pembrolizumab is allowed for patients who can afford it.
Exclusion criteria
Exclusion criteria: 1. A WOCBP with a positive urine pregnancy test unless MTP is done before randomization. 2. Has a known additional malignancy progressing or requiring active treatment within the past 3 years. ( Except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g., breast cancer) that have undergone potentially curative therapy). 3. Has an active infection requiring systemic therapy 4. Is currently participating in or has participated in a study of an investigational agent that can affect PFS. 5. Is pregnant or breastfeeding 6. Has had an allogeneic tissue/solid organ transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 month Progression free rateTimepoint: 6 month Progression free rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Median Progression free survival (mPFS) 2). median Overall Survival (OS) 3). Assessment of toxicities as per NCI CTCAE v5.0 4). To evaluate prognostic factors affecting PFS & OSTimepoint: median PFS at 10 months & OS at 15 months, when its expected that 50% of enrolled subjects would have had an event. Toxicities will be assessed with each cycle( every 21 days starting from day 21 & upto 30 days post administration of last dose of intervention drug. Prognostic factor evaluation at the stage of data analysis after study completion( 24 months). | — |
Countries
India
Contacts
Public ContactDr Babita Kataria
National Cancer Institute-AIIMS,Jhajjar, Haryana
Outcome results
None listed