Cervix Carcinoma Recurrent, Metastatic Carcinoma to the Uterine Cervix, Recurrent Carcinoma Cervix
Conditions
Keywords
recurrent or metastatic carcinoma cervix chemotherapy
Brief summary
Experience with substituting carboplatin for cisplatin is limited in advanced and recurrent cervix cancer and there has been no counterpart to GOG 158, which documented therapeutic equivalency of cisplatin/paclitaxel and carboplatin/paclitaxel for treatment of ovarian cancer, performed in a cervix cancer population.
Detailed description
This trial will be a prospective, randomized phase II pilot study. Consecutive patients of metastatic, recurrent or refractory carcinoma cervix enrolled in gynecology clinic at IRCH, AIIMS will be taken into study after taking informed consent. Patients will be randomized into two arms. Each arm shall contain 20 patients. The patients shall receive paclitaxel and carboplatin q3wk in first arm and paclitaxel and carboplatin q1 wk in second arm.
Interventions
Paclitaxel 60 mg/ m2 administered in 250 ml normal saline over 1 hour, and carboplatin AUC 2 administered in 250 ml 5%D over 1 hour. Therapy repeated every weekly
Sponsors
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1\. Histologically proven case of squamous or adenocarcinoma or adenosquamous carcinoma 2.ECOG performance status 0,1 and 2 3.Adequate hematologic, renal and liver functions 4.Informed consent 5.Measurable disease by CT scan or USG abdomen or MRI \-
Exclusion criteria
1. ECOG performance status 3 or 4 2. Impaired blood counts: those patients with an absolute neutrophil count \<1,500/μL, platelet counts \<100,000/μL, will be ineligible. 3. Impaired renal /liver functions as indicated by: Serum bilirubin \>1.5× normal, AST level more than 3× normal, Alkaline phosphatase level more than 3× institutional normal, or a Serum creatinine level more than 1.2 mg/dL. Patients with serum creatinine level of more than 1.2 mg/dL but less than 1.5 mg/dL are eligible if creatinine clearance is 70 ml/min were eligible if a creatinine clearance determination was more than 50 mL/min. 4\. H/o prior chemotherapy for metastatic disease, 5. H/O concurrent or past malignancy other than carcinoma cervix, 6. CNS metastasis, or 7. Bilateral hydronephrosis that could not be alleviated by ureteral stents or percutaneous nephrostomy. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression (length of time from start of chemotherapy to evidence of cancer progression. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Response rate | 6 months |
| Overall survival | 6 months |
| Quality Of Life Questionnaire | 6 months |
Countries
India
Outcome results
None listed