Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Ovarian Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/10/2017 |
| Start Date: | November 1999 |
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 Optimally Debulked Stage III Ovarian and Primary Peritoneal Carcinoma
Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem
cell transplantation in treating patients who have undergone surgery for stage III ovarian
cancer. 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.
cell transplantation in treating patients who have undergone surgery for stage III ovarian
cancer. 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.
OBJECTIVES:
I. Determine the safety and feasibility of multiple courses of high dose carboplatin,
paclitaxel, and topotecan as initial chemotherapy combined with autologous peripheral blood
stem cell transplantation in patients with optimally debulked stage III ovarian or primary
peritoneal carcinoma.
II. Determine the pathological complete response rate, disease free survival, and overall
survival in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Mobilization and harvest: Within 8 weeks of surgical debulking, patients receive
cyclophosphamide IV over 1 hour, followed 4 hours later by paclitaxel IV over 24 hours.
Patients receive filgrastim (G-CSF) subcutaneously (SQ) daily beginning 24 hours after
completion of paclitaxel infusion and continuing until blood counts recover and autologous
peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells.
High dose chemotherapy and transplantation (3 weeks after PBSC harvest): Patients receive
paclitaxel IV over 24 hours beginning on day 1, immediately followed by carboplatin IV over 2
hours, immediately followed by topotecan IV over 24 hours. Patients receive G-CSF
sub-cutaneously (SQ) daily beginning 24 hours after completion of topotecan infusion and
continuing until blood counts have recovered for 2 days. One quarter of the PBSC are
reinfused beginning 2 days after completion of topotecan infusion. Treatment repeats every 4
weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients
with radiographic and biochemical complete response undergo laparoscopy as second look
surgery within 8 weeks of the last course of chemotherapy. If no evidence of disease is found
during laparoscopy, then exploratory laparotomy must also be performed.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter or at time of recurrence until death.
I. Determine the safety and feasibility of multiple courses of high dose carboplatin,
paclitaxel, and topotecan as initial chemotherapy combined with autologous peripheral blood
stem cell transplantation in patients with optimally debulked stage III ovarian or primary
peritoneal carcinoma.
II. Determine the pathological complete response rate, disease free survival, and overall
survival in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Mobilization and harvest: Within 8 weeks of surgical debulking, patients receive
cyclophosphamide IV over 1 hour, followed 4 hours later by paclitaxel IV over 24 hours.
Patients receive filgrastim (G-CSF) subcutaneously (SQ) daily beginning 24 hours after
completion of paclitaxel infusion and continuing until blood counts recover and autologous
peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells.
High dose chemotherapy and transplantation (3 weeks after PBSC harvest): Patients receive
paclitaxel IV over 24 hours beginning on day 1, immediately followed by carboplatin IV over 2
hours, immediately followed by topotecan IV over 24 hours. Patients receive G-CSF
sub-cutaneously (SQ) daily beginning 24 hours after completion of topotecan infusion and
continuing until blood counts have recovered for 2 days. One quarter of the PBSC are
reinfused beginning 2 days after completion of topotecan infusion. Treatment repeats every 4
weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients
with radiographic and biochemical complete response undergo laparoscopy as second look
surgery within 8 weeks of the last course of chemotherapy. If no evidence of disease is found
during laparoscopy, then exploratory laparotomy must also be performed.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter or at time of recurrence until death.
Inclusion Criteria:
- Histologically proven optimally debulked stage III ovarian or primary peritoneal
carcinoma
- Any of the following subtypes:
- Serous adenocarcinoma
- Mucinous adenocarcinoma
- Clear cell carcinoma
- Transitional cell carcinoma
- Endometrioid adenocarcinoma
- Undifferentiated adenocarcinoma
- Mixed epithelial adenocarcinoma
- Adenocarcinoma, not otherwise specified
- No ovarian carcinoma of low malignant potential (borderline)
- Concurrent superficial endometrial or cervical carcinoma allowed if ovarian carcinoma
more life threatening or limiting
- Must have undergone appropriate primary surgical staging and debulking for ovarian
carcinoma and have less than 1 cm of residual disease
- No more than 8 weeks since prior surgical debulking
- Must have Hickman catheter in place or be eligible for placement
- No CNS involvement
- Performance status - GOG 0 or 1
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 mg/dL
- SGOT or SGPT no greater than 2 times upper limit of normal
- No active hepatitis
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- No renal failure
- Curatively treated ureteral obstruction allowed if above creatinine measurements met
- No congestive heart failure
- No myocardial infarction within the past 6 months
- No significant arrhythmias requiring medication
- No poorly controlled systolic or diastolic hypertension (diastolic blood pressure
consistently greater than 100 mm Hg)
- No significant nonneoplastic pulmonary disease
- No other malignancy within the past 5 years except basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix
- HIV negative
- No other severe medical or psychiatric illness including, but not limited to the
following:
- Acute infection
- Active peptic ulcer disease
- Uncontrolled diabetes mellitus
- Prior hospitalization for psychiatric illness, including severe depression or
psychosis
- Concurrent alcohol or drug abuse
- No prior chemotherapy for this malignancy
- No radiotherapy to greater than 25% of bone marrow
- See Disease Characteristics
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