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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00108745 |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and polyglutamate paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Paclitaxel and polyglutamate paclitaxel may also stop the growth of ovarian epithelial or peritoneal cancer by blocking blood flow to the tumor. Sometimes, after treatment, the tumor may not need additional treatment until it progresses.
In this case, observation may be sufficient. It is not yet known whether paclitaxel is more effective than polyglutamate paclitaxel or observation only in treating ovarian epithelial, peritoneal, or fallopian tube cancer.
PURPOSE: This randomized phase III trial is studying paclitaxel to see how well it works compared to polyglutamate paclitaxel or observation only in treating patients with stage III or stage IV ovarian epithelial or peritoneal cancer or fallopian tube cancer.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: paclitaxel Drug: paclitaxel poliglumex Procedure: observation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or Xyotax (CT-2103) (IND# 70177), Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian or Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy |
Estimated Enrollment: | 1100 |
Study Start Date: | March 2005 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.
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Drug: paclitaxel poliglumex
Given IV
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Arm II: Active Comparator
Patients receive paclitaxel IV over 3 hours on day 1.
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Drug: paclitaxel
Given IV
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Arm III: No Intervention
Patients receive no further anticancer treatment until evidence of disease progression.
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Procedure: observation
No intervention
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OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage at diagnosis (stage III vs stage IV); presence of macroscopic disease after initial debulking surgery (yes vs no); type of prior taxane-based therapy (docetaxel vs paclitaxel); and route of prior platinum therapy (intraperitoneal vs IV). Patients are randomized to 1 of 3 treatment arms.
In arms I and II, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before courses 3, 5, and 7 of study treatment, at completion of study treatment, and then at 1 year after completion of study treatment.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 1,110 patients (555 per treatment arm) will be accrued for this study within 8.5 years.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
The following histologic epithelial cell types are allowed:
The following histologic cell types are not allowed:
Low malignant potential (LMP) tumor (borderline carcinoma), including micropapillary serous carcinoma
Must have undergone surgery for ovarian epithelial or primary peritoneal cancer AND have tissue available for histologic evaluation
Must have completed at least 5, but no more that 8 courses of primary therapy comprising carboplatin (IV or intraperitoneal) AND paclitaxel or docetaxel-based combination chemotherapy within the past 12 weeks AND have no symptoms of persistent cancer after completion of therapy
Patients treated with neo-adjuvant platinum-taxane chemotherapy for a presumptive diagnosis of stage III or IV primary peritoneal carcinoma or epithelial ovarian carcinoma (by paracentesis, percutaneous biopsy or open biopsy) are eligible provided the following criteria is met:
Must have undergone interval abdominal surgery after at least one but no more than 6 courses of standard chemotherapy
No synchronous primary endometrial cancer or history of primary endometrial cancer, unless all of the following criteria are met:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Maurie Markman, MD | M.D. Anderson Cancer Center |
Investigator: | Robert A. Burger, MD | Chao Family Comprehensive Cancer Center |
Responsible Party: | Gynecologic Oncology Group ( Philip J. DiSaia ) |
Study ID Numbers: | CDR0000422427, GOG-0212 |
Study First Received: | April 18, 2005 |
Last Updated: | August 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00108745 History of Changes |
Health Authority: | Unspecified |
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer peritoneal cavity cancer ovarian clear cell cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian mixed epithelial carcinoma |
ovarian mucinous cystadenocarcinoma ovarian serous cystadenocarcinoma Brenner tumor ovarian undifferentiated adenocarcinoma fallopian tube cancer |
Cystadenocarcinoma, Serous Fallopian Tube Cancer Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Carcinoma, Endometrioid Genital Diseases, Female Peritoneal Diseases Ovarian Cancer Taxane Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female |
Endocrine System Diseases Antimitotic Agents Abdominal Neoplasms Ovarian Epithelial Cancer Fallopian Tube Neoplasms Carcinoma Digestive System Diseases Paclitaxel Tubulin Modulators Gastrointestinal Neoplasms Peritoneal Neoplasms Endocrinopathy Adenocarcinoma Antineoplastic Agents, Phytogenic |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Mitosis Modulators Genital Neoplasms, Female |
Endocrine System Diseases Antimitotic Agents Abdominal Neoplasms Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases Paclitaxel Tubulin Modulators Peritoneal Neoplasms Antineoplastic Agents, Phytogenic |