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NCT Number: NCT00006227

Paclitaxel in Treating Patients With Ovarian Stromal Cancer

This phase II trial studies the effectiveness of paclitaxel in treating patients who have ovarian stromal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

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Key information

Conditions

Adult Type Ovarian Granulosa Cell Tumor Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Gonadal Tissue Ovarian Diseases Ovarian Gynandroblastoma Ovarian Neoplasms Ovarian Sertoli-Leydig Cell Tumor Ovarian Sex Cord Tumor With Annular Tubules Ovarian Steroid Cell Tumor Sertoli-Leydig Cell Tumor Sex Cord-Gonadal Stromal Tumors Testicular Diseases Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Tohoku University School of Medicine, Sendai, Aoba-ku, Japan

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About this study

PRIMARY OBJECTIVES:

I. To estimate the probability of clinical response and toxicity of paclitaxel as second-line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma.

II. To evaluate the value of inhibin for predicting response.

OUTLINE:

Patients receive paclitaxel intravenously (IV) over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, then every 6 months for three years, and then annually thereafter.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with histologically confirmed ovarian stromal tumor (granulosa cell tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor [androblastoma], steroid [lipid] cell tumor, gynandroblastoma, unclassified sex cord stromal tumor, sex cord tumor with annular tubules)
  • Patients must have recurrent stromal tumor having received no more than one prior chemotherapy regimen
  • Patients must have measurable disease as defined by Gynecological Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • White blood count equal to or greater than 3000/mcl
  • Granulocyte count equal to or greater than 1500/mcl
  • Platelet count equal to or greater than 100,000/mcl
  • Creatinine equal to or less than 2.0 mg%
  • Bilirubin less than or equal to 1.5 times normal
  • Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 times normal
  • Patients with a GOG performance grade of 0, 1 or 2
  • Patients of child bearing potential must have a negative pregnancy test and must agree to practice an effective means of birth control
  • Patients who have met the pre-entry requirements as specified
  • Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

Exclusion criteria

  • Patients with GOG performance grade of 3 or 4
  • Patients with a prior invasive malignancy (except non-melanoma skin cancer) who have had any evidence of disease within the last 5 years or whose prior malignancy treatment contraindicates the current protocol therapy
  • Patients having received more than one prior chemotherapy regimen
  • Patients amenable to cure by surgery
  • Patients with prior radiation except for those whose recurrent disease is outside the radiation port

Treatment and study plan

paclitaxel

Drug

Given IV

Primary outcomes

  1. Probability of Complete Clinical Response

    Time frame: Up to 5 years

    The probability of complete clinical response (i.e. proportion of participants) (assessed using GOG RECIST criteria) of paclitaxel as second line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma

Secondary outcomes

  1. Progression-free Survival

    Time frame: The period from study entry until disease progression, death or date of last contact

    Duration of progression free survival (median) (months)

  2. Overall Survival

    Time frame: The observed length of life from entry into the study to death or the date of last contact

    Duration of overall survival (median) (months)

Sponsors and collaborators

Lead sponsor

Gynecologic Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy

Important dates

Study start
2000
Primary completion
2016
Study completion
2016
First posted
Jan 27, 2003
Registry last updated
Mar 5, 2020

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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