Paclitaxel and Carboplatin Combination as 1st Line Treatment in Ovarian Carcinomas

Dose Dense Administration of Paclitaxel and Carboplatin Combination as 1st Line Treatment in Patients With Ovarian Carcinoma

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00750386

Enrollment

Registered

2008-09-10

Start date

2008-01-31

Completion date

2011-03-31

Last updated

2011-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

Cancer, Ovarian cancer, Dose-dense chemotherapy

Brief summary

This trial will determine the feasibility and toxicity of dose intense (every 2 weeks) of paclitaxel+carboplatin combination following cytoreductive surgery in patients with stage Ic-IV ovarian cancer.

Detailed description

Dose dense chemotherapy has been proven beneficial in various oncological settings. It is proposed that this concept be tested in ovarian cancer, with the support of growth factors. It is hypothesized that, if feasible, dose-dense chemotherapy may be more effective.

Interventions

DRUGPaclitaxel

175 mg/m2, I.V, every 2 weeks

DRUGCarboplatin

Carboplatin AUC, I.V, 5 every 2 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Histologically- or cytologically- confirmed ovarian cancer requiring standard chemotherapy * Patients have to be chemotherapy naive * Patients may have undergone cytoreductive surgery, or this may have been omitted due to dissemination * Age \>18 years. * Performance status (WHO) 0-2 * Life expectancy of at least three months. * Adequate bone marrow function (Absolute neutrophil count \>1000/mm\^3, Platelet count\>100000/mm\^3, Hemoglobin\>9gr/mm\^3). * Adequate liver (Bilirubin\<1.5 times upper limit of normal and SGOT/SGPT\<2 times upper limit of normal) and renal function (creatinine\<2mg/dl) * Informed consent

Exclusion criteria

* Pregnant or nursing * Psychiatric illness or social situation that would preclude study compliance' * Other concurrent uncontrolled illness * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

Design outcomes

Primary

Measure	Time frame
Determine the maximum tolerated dose and the response rate	Toxicity assestment of the 1st cycle for the first 10 patients. Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary

Measure	Time frame
Toxicity profile	Toxicity assessment on each cycle
Time to tumor progression	1 year

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026