Effectiveness of Chemotherapy in Metastatic or Recurrent Carcinoma Cervix

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT02492503
• Date of registration: 08/01/2014
• Prospective Registration: No
• Primary sponsor: All India Institute of Medical Sciences, New Delhi
• Public title: Effectiveness of Chemotherapy in Metastatic or Recurrent Carcinoma Cervix
• Scientific title: An Open Label Randomized Phase 2, Pilot Study to Investigate the Effectiveness of Palliative Chemotherapy in Stage IVB, Recurrent or Persistent Carcinoma Cervix
• Date of first enrolment: November 2013
• Target sample size: 40
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02492503
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

India

Contacts

• Name: lalit kumar, MD,DM
• Affiliation: All India Institute of Medical Sciences, New Delhi

Key inclusion & exclusion criteria

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.

-



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Cervix Carcinoma Recurrent

Metastatic Carcinoma to the Uterine Cervix

Recurrent Carcinoma Cervix

Intervention(s)

Drug: Paclitaxel and carboplatin

Primary Outcome(s)

Time to progression (length of time from start of chemotherapy to evidence of cancer progression. [Time Frame: 6 months]

Secondary Outcome(s)

Overall survival [Time Frame: 6 months]

Response rate [Time Frame: 6 months]

Quality Of Life Questionnaire [Time Frame: 6 months]

Secondary ID(s)

CA CX CHEMOTHERAPY

Source(s) of Monetary Support

Please refer to primary and secondary sponsors