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| Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003896 |
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, cisplatin, and liposomal doxorubicin in treating women who have undergone surgery for stage III ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: cisplatin Drug: paclitaxel Drug: pegylated liposomal doxorubicin hydrochloride Procedure: adjuvant therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian Cancer |
| Estimated Enrollment: | 62 |
| Study Start Date: | September 1999 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 3 hours on day 1, intraperitoneal (IP) cisplatin over 30-60 minutes on day 2, IP paclitaxel over 30-60 minutes on day 8, and doxorubicin HCl liposome IV over 1 hour on day 8. Patients not able to tolerate IP infusion receive paclitaxel IV and cisplatin IV on day 1 only.
Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage III ovarian epithelial, fallopian tube, or primary peritoneal carcinoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 104 Study Locations| Study Chair: | Harriet O. Smith, MD | University of New Mexico |
More Information
| Study ID Numbers: | CDR0000067066, SWOG-S9912 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003896 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III ovarian epithelial cancer peritoneal cavity cancer fallopian tube cancer |
|
Fallopian Tube Cancer Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Anti-Bacterial Agents Cisplatin Peritoneal Diseases Ovarian Cancer Endocrine Gland Neoplasms Digestive System Neoplasms Ovarian Neoplasms Genital Neoplasms, Female Adjuvants, Immunologic Endocrine System Diseases |
Antimitotic Agents Abdominal Neoplasms Ovarian Epithelial Cancer Fallopian Tube Neoplasms Doxorubicin Fallopian Tube Diseases Digestive System Diseases Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Gastrointestinal Neoplasms Peritoneal Neoplasms Endocrinopathy Antineoplastic Agents, Phytogenic |
|
Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Antibiotics, Antineoplastic Genital Diseases, Female Neoplasms by Site Cisplatin 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 Doxorubicin Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators |