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| Sponsors and Collaborators: |
Fox Chase Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | Fox Chase Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003944 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: paclitaxel Drug: topotecan hydrochloride Procedure: peripheral blood stem cell transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Trial Using Multiple Cycles of High Dose Sequential Carboplatin, Paclitaxel and Topotecan With Peripheral Blood Stem Cell (PBSC) Support as Initial Chemotherapy in Patients With Suboptimally Debulked Stage III or IV Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma |
| Estimated Enrollment: | 28 |
| Study Start Date: | August 1998 |
| Estimated Study Completion Date: | February 2003 |
| Primary Completion Date: | December 1999 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Determine pathological complete response rate in patients with suboptimally debulked stage III or stage IV ovarian, fallopian tube, or primary peritoneal carcinoma treated with sequential paclitaxel, carboplatin, and topotecan with peripheral blood stem cell rescue. II. Determine disease free and overall survival of these patients.
OUTLINE: Patients receive mobilization with cyclophosphamide IV over 1 hour, followed 4 hours later by paclitaxel IV over 24 hours. Filgrastim (G-CSF) is administered subcutaneously beginning 24 hours after completion of paclitaxel and continues through stem cell harvest. Peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells. High dose sequential chemotherapy begins 21 days after leukapheresis. Patients receive paclitaxel IV over 24 hours on day 1, carboplatin IV over 2 hours on day 2, and then topotecan IV over 24 hours.
G-CSF is administered subcutaneously beginning on day 3 until blood counts recover. PBSC are reinfused on day 4.
Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with radiographic and biochemical complete response undergo second look surgery within 8 weeks of completing the last course of chemotherapy.
PROJECTED ACCRUAL: Approximately 28 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven ovarian, fallopian tube, or primary peritoneal carcinoma Suboptimally debulked stage III (greater than 1.0 cm residual disease) Stage IV Histological subtypes allowed include: Serous adenocarcinoma Mucinous adenocarcinoma Clear cell carcinoma Transitional cell carcinoma Endometrioid adenocarcinoma Undifferentiated adenocarcinoma Mixed epithelial adenocarcinoma Adenocarcinoma not otherwise specified No borderline ovarian carcinoma of low malignant potential histology Stage III disease patients must have had appropriate surgery for ovarian, fallopian tube, and primary peritoneal carcinoma and retained suboptimally debulked disease (greater than 1.0 cm residual disease) No CNS involvement
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0 or 1 Life expectancy: Not specified
Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic:
Bilirubin no greater than 1.5 mg/dL AST and ALT no greater than 2 times upper limit of normal Hepatitis negative Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Ureteral obstruction must be successfully treated No renal failure Cardiovascular: No congestive heart failure No myocardial infarction within past 6 months No significant arrhythmias requiring medication No poorly controlled hypertension No poorly controlled systolic blood pressure No diastolic blood pressure consistently greater than 100 mmHg Pulmonary: No significant non-neoplastic pulmonary disease Other: No other severe medical disease HIV negative No prior malignancy within past 5 years except squamous or basal cell carcinoma of the skin, or carcinoma in situ of the cervix Second concurrent solid tumor malignancy allowed if not life threatening and if does not require chemotherapy or radiotherapy No acute infection No active peptic ulcer disease No uncontrolled diabetes mellitus No current psychiatric disease, alcohol abuse, or drug abuse No prior hospitalization for psychiatric disease including severe depression or psychosis Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No hypersensitivity to E. coli derived products
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to greater than 25% of bone marrow Surgery: See Disease Characteristics No greater than 8 weeks since debulking surgery
Contacts and Locations| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Study Chair: | Russell J. Schilder, MD | Fox Chase Cancer Center |
More Information
| Responsible Party: | FCCC ( Russell Schilder, MD ) |
| Study ID Numbers: | CDR0000067137, FCCC-98030, NCI-G99-1536 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003944 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 peritoneal cavity cancer |
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Cystadenocarcinoma, Serous Fallopian Tube Cancer Immunologic Factors Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Cyclophosphamide Carcinoma, Endometrioid Genital Diseases, Female Peritoneal Diseases Ovarian Cancer Alkylating Agents Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms |
Genital Neoplasms, Female Endocrine System Diseases Antimitotic Agents Carboplatin Abdominal Neoplasms Ovarian Epithelial Cancer Immunosuppressive Agents Fallopian Tube Neoplasms Carcinoma Digestive System Diseases Paclitaxel Tubulin Modulators Gastrointestinal Neoplasms Antineoplastic Agents, Alkylating Peritoneal Neoplasms |
|
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Cyclophosphamide Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Alkylating Agents Endocrine Gland Neoplasms Ovarian Neoplasms |
Digestive System Neoplasms Mitosis Modulators Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Antimitotic Agents Carboplatin Abdominal Neoplasms Immunosuppressive Agents Pharmacologic Actions Fallopian Tube Neoplasms Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases |
