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NCT Number: NCT00189553

Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse

This is a study of the efficacy and safety of Caelyx (pegylated liposomal doxorubicin) in combination with carboplatin compared to the standard treatment of paclitaxel and carboplatin in patients with epithelial ovarian cancer in late relapse (> 6 months).

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms 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 and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Hôtel Dieu

Paris, 75004, France

About this study

The main purpose of this research study is to find out if treatment of late relapse of ovarian or fallopian tube or primary peritoneal cancer with liposomal doxorubicin (Caelyx) combined with carboplatin will control the tumor growth at least as well as standard treatment of paclitaxel and carboplatin. And it is hoped that substituting paclitaxel with Caelyx in combination with carboplatin will improve the tolerance of the treatment program with at least the same efficacy and fewer side effects.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged > 18
  • Histologically proven diagnosis of cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors
  • Measurable disease (Response Evaluation Criteria in Solid Tumor [RECIST] criteria) or cancer antigen (CA) 125 assessable disease (Gynecologic Cancer Intergroup [GCIG] criteria) or with histologically proven diagnosis of relapse
  • Disease in progression > 6 months after a first or second platinum-based line. Patients should have previously received a taxane derivative.
  • ECOG performance status < 2
  • Life expectancy of at least 12 weeks
  • Adequate bone marrow, renal, and hepatic function

Exclusion criteria

  • Ovarian tumors of low malignant potential
  • Non-epithelial ovarian or mixed epithelial/non-epithelial tumors
  • Previous radiotherapy
  • Prior diagnosis of malignancy
  • Bowel obstruction, sub-occlusive disease, or presence of symptomatic brain metastases
  • Pre-existing motor or sensory neurologic pathology or symptoms National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) grade > 1
  • History of congestive heart failure (New York Heart Association [NYHA] classification > 2), history of myocardial infarction within the last 6 months, or history of atrial or ventricular arrhythmias
  • Severe active infection
  • Severe hypersensitivity to products containing Cremophor EL and/or to compounds chemically related to paclitaxel, carboplatin or Caelyx
  • Fertile women not using adequate contraceptive methods
  • Pregnant or breast feeding women

Treatment and study plan

Pegylated liposomal doxorubicin

Drug

30 mg/m² every 4 weeks during 6 cycles or until progression

Other names: Caelyx

carboplatin

Drug

AUC 5 every 3/4 weeks during 6 cycles or until progression

Other names: generic drug

paclitaxel

Drug

175 mg/m² at day 1 every 3 weeks during 6 cycles or until progression

Other names: generic drug

Primary outcomes

  1. Progression-free survival of patients in both study groups

    Time frame: 5 years

Secondary outcomes

  1. Qualitative and quantitative toxicities

    Time frame: 6 months

  2. Quality of life

    Time frame: 6 months

  3. Overall survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

ARCAGY/ GINECO GROUP

Other

Collaborators

  • AGO Study Group
  • Arbeitsgemeinschaft Gynaekologische Onkologie Austria
  • Australia New Zealand Gynaecological Oncology Group
  • European Organisation for Research and Treatment of Cancer - EORTC
  • NCIC Clinical Trials Group
  • NSGO
  • Schering-Plough

Registry information

Official study title

A Multi-National,Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin and Carboplatin Versus Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse (> 6 Months)

Acronym: CALYPSO

Important dates

Study start
2005
Primary completion
2009
Study completion
2012
First posted
Sep 19, 2005
Registry last updated
Jan 10, 2014

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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