Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity Cancer
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Purpose
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 relapsed stage III or stage IV ovarian epithelial or primary peritoneal cavity cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Peritoneal Cavity Cancer |
Biological: pegfilgrastim Drug: carboplatin Drug: docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Docetaxel and Carboplatin for First Relapsed Platinum-Sensitive Stage III and IV Advanced Ovarian Cancer or Peritoneal Carcinoma |
- Toxicity [ Designated as safety issue: Yes ]
- Response rates (complete and partial response) [ Designated as safety issue: No ]
- Relapse rates [ Designated as safety issue: No ]
- Event-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Study Start Date: | May 2005 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the toxicity of docetaxel and carboplatin in patients with platinum-sensitive stage III or IV ovarian epithelial or primary peritoneal cavity cancer in first relapse.
- Determine the response rates (complete and partial response) in patients treated with this regimen.
- Determine relapse rates and event-free survival and overall survival rates in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2 . Treatment repeats every 21 days for up to 6 courses.
After completion of study treatment, patients are followed at 3 weeks, every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer
- Stage III or IV disease
- No borderline tumors
Measurable or evaluable disease
- Measurable disease, defined as evidence of disease by physical examination or radiographic evaluation
- Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests performed ≥ 1 week apart)
In first relapse
- Platinum-sensitive disease, defined as initial relapse > 6 months after completion of a platinum-based regimen
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Platelet count ≥ 100,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
Hepatic
- Bilirubin normal
Meets 1 of the following criteria:
- SGOT and/or SGPT ≤ 1.5 times upper limit of normal (ULN) AND alkaline phosphatase (AP) ≤ 2.5 times ULN
- SGOT and/or SGPT ≤ 5.0 times ULN AND AP normal
Renal
- Creatinine ≤ 2.0 mg/dL
- Creatinine clearance > 50 mL/min
Cardiovascular
- LVEF ≥ 50%
- No poorly controlled arrhythmia
- No unstable coronary artery disease or myocardial infarction within the past year
Other
- HIV negative
- No pre-existing peripheral neuropathy > grade 2
- No history of allergy to study drugs
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy and recovered
Endocrine therapy
- Not specified
Radiotherapy
- At least 3 weeks since prior radiotherapy and recovered
Surgery
- Recovered from recent prior surgery
Other
- No concurrent myelosuppressive therapy
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Pacific Gynecology Specialists | |
| Seattle, Washington, United States, 98104 | |
| University of Washington School of Medicine | |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: | Leona A. Holmberg, MD, PhD | Fred Hutchinson Cancer Research Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00217568 History of Changes |
| Other Study ID Numbers: | PSOC 1702, PSOC-1702, AVENTIS-PSOC-1702, PSOC-IRB-4861, CDR0000441307 |
| Study First Received: | September 20, 2005 |
| Last Updated: | September 20, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
recurrent ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Docetaxel Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013