Effectiveness of Chemotherapy in Metastatic or Recurrent Carcinoma Cervix

NCT02492503 | Unknown Phase 1

• 1 other identifier: CA CX CHEMOTHERAPY
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Carcinoma to the Uterine Cervix; Recurrent Carcinoma Cervix; Cervix Carcinoma Recurrent

Keywords

recurrent or metastatic carcinoma cervix chemotherapy

Outcome Measures

Primary Outcomes (1)

• Time to progression (length of time from start of chemotherapy to evidence of cancer progression.

  6 months

Secondary Outcomes (3)

• Response rate

  6 months

• Overall survival

  6 months

• Quality Of Life Questionnaire

  6 months

Study Arms (2)

pacli carb 3

ACTIVE COMPARATOR

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

Drug: Paclitaxel and carboplatin

pacli carb 1

ACTIVE COMPARATOR

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

Drug: Paclitaxel and carboplatin

Interventions

Paclitaxel and carboplatin DRUG

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

Also known as: Arm1

pacli carb 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• ECOG performance status 3 or 4
• Impaired blood counts: those patients with an absolute neutrophil count \<1,500/μL, platelet counts \<100,000/μL, will be ineligible.
• 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.
• \. 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

AIIMS

New Delhi, New Delhi, 110029, India

Location

Related Links

• Witteveen PO et al

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Recurrence

Interventions

Paclitaxel; Carboplatin; 26S proteasome non-ATPase regulatory subunit 13; DMAC2L protein, human

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• lalit kumar, MD,DM

  All India Institute of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior resident

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: July 8, 2015
• Study Start: November 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

IN (1)