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Completed

NCT Number: NCT00035100

EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause ovarian, fallopian, or peritoneal cancers. Recruitment in the United States is complete but the study is still enrolling in other countries.

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Key information

Conditions

Ovarian Neoplasms Abdominal Neoplasms Adnexal Diseases Carcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases 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 Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Peritoneal Diseases Peritoneal Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The following patients may be eligible for the study:

  • Histologically or cytologically documented evidence of ovarian, primary Fallopian or primary peritoneal cancer with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
  • Must have a life expectancy of greater than three (3) months
  • Prior failure to respond following front-line treatment with a taxane and platinum (or a combination therapy) may be eligible.

Exclusion criteria

The following patients are not eligible for the study:

  • Patients with radiation therapy or chemotherapy within the last four weeks
  • Patients who have had any chemotherapy not containing a taxane and platinum for their disease
  • Patients with borderline ovarian and macropapillary tumors
  • Patients with unresolved bowel obstruction
  • Patients with symptomatic CNS metastases or leptomeningeal involvement
  • Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
  • Patients with severe cardiac insufficiency
  • Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
  • History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer or cervical cancer in situ
  • Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
  • HIV+ patients
  • Pregnant or lactating females.

Treatment and study plan

epothilone b

Drug

Other names: EPO906

Primary outcomes

  1. Tumor response rate

    Time frame: Every 2 cycles

    tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST).

Secondary outcomes

  1. Time to disease progression

    Time frame: from start of treatment to documented disease progression, death from study indication, or the date of last follow-up

  2. Overall survival

    Time frame: measured from the start of treatment to the date of death or the last date the patient was known to be alive.

  3. Duration of response

    Time frame: Every 3 months

    duration of response in patients with complete response (CR) or partial response (PR)

  4. recording all adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Every 3 months

    Safety and tolerability of patupilone by monitoring and recording all AEs and SAEs, regular monitoring of hematology, blood chemistry and urine lalues, vital signs, ECG and physical examinations

  5. pharmacogenetic analyses with blood and tumor samples from these patients

    Time frame: Every 3 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer

Important dates

Study start
2001
Primary completion
2003
First posted
May 3, 2002
Registry last updated
Apr 16, 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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