Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer
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| ClinicalTrials.gov Identifier: NCT00003385 |
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Recruitment Status
:
Completed
First Posted
: January 27, 2003
Last Update Posted
: May 27, 2013
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer | Drug: carboplatin Drug: paclitaxel Drug: pegylated liposomal doxorubicin hydrochloride | Phase 1 |
OBJECTIVES:
- Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with paclitaxel and carboplatin in patients with previously untreated ovarian epithelial, peritoneal, or fallopian tube cancer.
- Determine the toxicity of this treatment regimen in these patients.
- Evaluate measurable disease in patients treated with this regimen.
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 48 participants |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I Study of Paclitaxel, Carboplatin, and Increasing Doses of Doxil in Untreated Ovarian, Peritoneal, and Tubal Carcinoma |
| Study Start Date : | March 1999 |
| Actual Primary Completion Date : | January 2007 |
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed previously untreated ovarian epithelial carcinoma, peritoneal carcinoma, or fallopian tube carcinoma
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The following histologic epithelial cell types are eligible:
- Serous adenocarcinoma
- Endometrioid adenocarcinoma
- Mucinous adenocarcinoma
- Undifferentiated carcinoma
- Clear cell adenocarcinoma
- Mixed epithelial carcinoma
- Transitional cell
- Malignant Brenner tumor
- Adenocarcinoma not otherwise specified
- No more than 12 weeks since diagnosis
- No ovarian epithelial carcinoma of low malignant potential (borderline carcinomas)
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- GOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Absolute granulocyte count at least 1,500/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times normal
- SGOT/SGPT no greater than 3 times normal
- Alkaline phosphatase no greater than 3 times normal
- Gamma-glutamyl-transferase no greater than 3 times normal
- No acute hepatitis
Renal:
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance greater than 50 mL/min
Cardiovascular:
- LVEF normal by MUGA
- No unstable angina
- No myocardial infarction within the past 6 months
- Patients with abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible if disease has been stable for the past 6 months
Other:
- No septicemia or severe infection
- No severe gastrointestinal bleeding
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- Recovered from recent prior surgery
Other:
- No prior anticancer therapy that would preclude study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003385
| United States, Hawaii | |
| MBCCOP - Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center | |
| Iowa City, Iowa, United States, 52242-1009 | |
| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| United States, Ohio | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Texas | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0587 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Norway | |
| Norwegian Radium Hospital | |
| Oslo, Norway, N-0310 | |
| Study Chair: | Peter G. Rose, MD | MetroHealth Cancer Care Center at MetroHealth Medical Center |
Publications of Results:
| ClinicalTrials.gov Identifier: | NCT00003385 History of Changes |
| Other Study ID Numbers: |
CDR0000066381 GOG-9703 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | May 27, 2013 |
| Last Verified: | September 2003 |
Keywords provided by Gynecologic Oncology Group:
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stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer ovarian undifferentiated adenocarcinoma ovarian mixed epithelial carcinoma ovarian serous cystadenocarcinoma |
ovarian mucinous cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian clear cell cystadenocarcinoma fallopian tube cancer primary peritoneal cavity cancer Brenner tumor |
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms Peritoneal Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Paclitaxel |
Liposomal doxorubicin Albumin-Bound Paclitaxel Carboplatin Doxorubicin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |