Clinical trial NCT02492503: Effectiveness of Chemotherapy in Metastatic or Recurrent Carcinoma Cervix
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Metastatic Carcinoma to the Uterine Cervix
Recurrent Carcinoma Cervix
Cervix Carcinoma Recurrent
Keywords: recurrent or metastatic carcinoma cervix chemotherapy
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2015-07-08
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

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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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Primary outcomes:
measure: Time to progression (length of time from start of chemotherapy to evidence of cancer progression.
timeFrame: 6 months
Secondary outcomes:
measure: Response rate
timeFrame: 6 months
measure: Overall survival
timeFrame: 6 months
measure: Quality Of Life Questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: AIIMS
Study officials:
affiliation: All India Institute of Medical Sciences
name: lalit kumar, MD,DM
role: STUDY_CHAIR
References: