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Completed

NCT Number: NCT00067314

Study in Women With Metastatic Breast Cancer Whose Cancer Has Gotten Worse After Anthracycline and Taxane Therapy

This international study will study how metastatic breast cancer responds to the investigational drug treatment, what are the side effects of the investigational drug when given to women with metastatic breast cancer and how often do these side effects occur. The study will also analyze how fast investigational drug and its breakdown products are cleared from the blood in these patients.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, East Bentleigh, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Locally advanced or metastatic breast cancer not amenable to surgery or radiation with curative intent
  • Must have received any chemotherapy regimen in the past
  • Evidence of tumor resistance to last chemotherapy defined as progression after 6 months of previous chemotherapy for advanced disease
  • Must have measurable (by imaging techniques) disease
  • Adequate bone marrow, liver and renal function
  • Must provide evidence of informed consent and willingness and ability to comply with scheduled visits, treatment plan and study procedures.

Exclusion criteria

  • Received more than 2 prior chemotherapy regimens for metastatic disease
  • Received in the past another drug of the same class as the investigational drug, i.e. topoisomerase I inhibitor
  • Enrolled in another clinical intervention study
  • Pregnancy, breast feeding, fertile women refusing to use reliable contraceptive methods
  • Cardiac or thrombotic event in the last 12 months
  • Brain metastases

Treatment and study plan

Edotecarin

Drug

Primary outcomes

  1. To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate

Secondary outcomes

  1. Time to tumor response (TAR)

  2. Duration of response (DR)

  3. Time to tumor progression (TTP)

  4. Time to treatment failure (TTF)

  5. Overall survival (OS)

  6. Clinical benefit

  7. ie, a composite profile of pain intensity

  8. analgesic consumption and performance status (pain and analgesic consumption to be measured as described in Purohit 1994 [18]

  9. performance status to be assessed using the Eastern Cooperative Oncology Group ([ECOG]) scale [Appendix 2]

  10. Overall safety profile characterized by type, frequency, severity (as graded by version 2.0 of the National Cancer Institute (NCI) Common Toxicity Criteria [CTC]

  11. [Appendix 3], timing and relationship to study therapy of adverse events and laboratory abnormalities.

  12. Plasma pharmacokinetic parameters

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase II Study Of Intravenous Edotecarin (PHA-782615) In Patients With Anthracycline- And Taxane Resistant Metastatic Breast Cancer

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Aug 18, 2003
Registry last updated
Jan 18, 2012

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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