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NCT Number: NCT00750386

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

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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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Hospital of Crete, Heraklion, Crete, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paclitaxel

Drug

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

carboplatin

Drug

Carboplatin AUC, I.V, 5 every 2 weeks

Primary outcomes

  1. Determine the maximum tolerated dose and the response rate

    Time frame: Toxicity assestment of the 1st cycle for the first 10 patients. Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary outcomes

  1. Toxicity profile

    Time frame: Toxicity assessment on each cycle

  2. Time to tumor progression

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Hellenic Oncology Research Group

Other

Collaborators

  • University Hospital of Crete

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 10, 2008
Registry last updated
May 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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