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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ovarian Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Paclitaxel/Carboplatin

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type DRUG

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

Carboplatin

Intervention Type DRUG

Carboplatin AUC, I.V, 5 every 2 weeks

Interventions

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Paclitaxel

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

Intervention Type DRUG

Carboplatin

Carboplatin AUC, I.V, 5 every 2 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No