Effectiveness of Chemotherapy in Metastatic or Recurrent Carcinoma Cervix

Cervix Carcinoma Recurrent Clinical Trial

Official title:

An Open Label Randomized Phase 2, Pilot Study to Investigate the Effectiveness of Palliative Chemotherapy in Stage IVB, Recurrent or Persistent Carcinoma Cervix

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02492503
• Other study ID #: CA CX CHEMOTHERAPY
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: January 8, 2014
• Last updated: July 7, 2015
• Start date: November 2013
• Est. completion date: August 2015

Study information

• Verified date: July 2015
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Cervix Carcinoma Recurrent
• Metastatic Carcinoma to the Uterine Cervix
• Recurrent Carcinoma Cervix
• Uterine Cervical Neoplasms

Intervention

Drug:
• Paclitaxel and carboplatin
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
• Paclitaxel and carboplatin
Paclitaxel 175 mg/ m2 administered in 250 ml normal saline over 3 hours and carboplatin AUC 4-5 administered in 250 ml 5%D over 2 hours. Therapy repeated every three weekly

Locations

Country	Name	City	State
India	AIIMS	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression (length of time from start of chemotherapy to evidence of cancer progression.		6 months	Yes
Secondary	Response rate		6 months	No
Secondary	Overall survival		6 months	Yes
Secondary	Quality Of Life Questionnaire		6 months	Yes

External Links

•   Kitagawa R, Katsumata N, Shibata T, et al
•   Witteveen PO et al