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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000439927 | Registry Identifier | PDQ (Physician Data Query) | |
| AVENTIS-VMRC-8837 |
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RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with carboplatin works in treating patients with ovarian epithelial, fallopian tube, or peritoneal cavity cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive docetaxel IV and carboplatin IV on days 1, 8, 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then undergo optional second-look surgery. After completion of 6 courses of chemotherapy (and second-look surgery, if applicable), patients may receive consolidation and/or salvage therapy at the discretion of the investigator.
Quality of life is assessed at baseline, before each treatment course, at the completion of study treatment, and then annually for 2 years.
After completion of study treatment, patients are followed annually for 2 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| docetaxel | Drug | |||
| adjuvant therapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction rate of myelosuppression |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life as assessed by the Functional Assessment of Cancer Therapy -Ovarian (FACT-O) questionnaire | ||
| Toxicity | ||
| Clinical response rate |
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DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or peritoneal cavity cancer
Underwent initial surgical management, including staging, of early stage disease or surgical debulking of advanced stage disease* NOTE: *Patients may delay surgical debulking, if clinically indicated, until after study entry; these patients may receive several courses of neoadjuvant chemotherapy prior to surgical debulking, but before study entry
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Bilirubin normal
Meets 1 of the following criteria:
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Howard G. Muntz, MD | Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center | Seattle | Washington | 98111-0900 | United States |
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| Findings at second look surgery |
| Time to disease progression |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| 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 |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| D017024 | Chemotherapy, Adjuvant |
| 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 |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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