Effectiveness of Chemotherapy in Metastatic or Recurrent Carcinoma Cervix

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

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.

Study Overview

• Status: Unknown
• Conditions: Metastatic Carcinoma to the Uterine Cervix; Recurrent Carcinoma Cervix; Cervix Carcinoma Recurrent
• Intervention / Treatment: Drug: Paclitaxel and carboplatin; Drug: Paclitaxel and carboplatin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• India
  • New Delhi, India, 110029
    • AIIMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

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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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: pacli carb 3; 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; 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; Other Names: Arm1; Drug: 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; Other Names: Arm 2
ACTIVE_COMPARATOR: pacli carb 1; 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; 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; Other Names: Arm1; Drug: 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; Other Names: Arm 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to progression (length of time from start of chemotherapy to evidence of cancer progression.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	6 months
Response rate	6 months
Quality Of Life Questionnaire	6 months

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, New Delhi
• Investigators: Study Chair: lalit kumar, MD,DM, All India Institute of Medical Sciences, New Delhi

Publications and helpful links

Helpful Links

• Witteveen PO et al

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ANTICIPATED): August 1, 2015
• Study Completion (ANTICIPATED): August 1, 2015

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: July 7, 2015
• First Posted (ESTIMATE): July 8, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): July 8, 2015
• Last Update Submitted That Met QC Criteria: July 7, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: recurrent or metastatic carcinoma cervix chemotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Carcinoma; Recurrence; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: CA CX CHEMOTHERAPY