Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GOG-9703 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy use 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 I trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin, paclitaxel, and carboplatin in treating patients who have untreated ovarian, peritoneal, or fallopian tube cancer.
OBJECTIVES:
OUTLINE: This is a dose-escalation study of doxorubicin HCl liposome (LipoDox).
Patients receive LipoDox IV on day 1, carboplatin IV over 3 hours on days 1 and 22, and paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 4 courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of LipoDox until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional cohort of 12 patients receives LipoDox at the MTD with carboplatin and paclitaxel as above.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study within 2 years.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| paclitaxel | Drug | |||
| pegylated liposomal doxorubicin hydrochloride | Drug |
DISEASE CHARACTERISTICS:
Histologically confirmed previously untreated ovarian epithelial carcinoma, peritoneal carcinoma, or fallopian tube carcinoma
The following histologic epithelial cell types are eligible:
No more than 12 weeks since diagnosis
No ovarian epithelial carcinoma of low malignant potential (borderline carcinomas)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter G. Rose, MD | MetroHealth Cancer Care Center at MetroHealth Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MBCCOP - Hawaii | Honolulu | Hawaii | 96813 | United States | ||
| Holden Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16959305 | Result | Rose PG, Greer BE, Horowitz IR, Markman M, Fusco N. Paclitaxel, carboplatin and pegylated liposomal doxorubicin in ovarian and peritoneal carcinoma: a phase I study of the Gynecologic Oncology Group. Gynecol Oncol. 2007 Jan;104(1):114-9. doi: 10.1016/j.ygyno.2006.07.036. Epub 2006 Sep 7. | |
| Result | Rose PG, Greer BE, Markman M, et al.: A phase I study of paclitaxel, carboplatin, and liposomal doxorubicin in ovarian, peritoneal, and tubal carcinoma: a Gynecologic Oncology Group Study. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A-1531, 2000. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Iowa City |
| Iowa |
| 52242-1009 |
| United States |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland | 20892-1182 | United States |
| Ireland Cancer Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0587 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | United States |
| Norwegian Radium Hospital | Oslo | N-0310 | Norway |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D001948 | Brenner Tumor |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018225 | Neoplasms, Fibroepithelial |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided