Status:
COMPLETED
Topotecan, High-Dose Cyclophosphamide, Carboplatin, and an Autologous Peripheral Blood Cell Transplant in Treating Patients With Recurrent Ovarian Cancer or Primary Peritoneal Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Ovarian Cancer
Peritoneal Cavity Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
Brief Summary
RATIONALE: Giving colony-stimulating factors, such as G-CSF help stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Combination chemotherapy is then given...
Detailed Description
OBJECTIVES: * To determine the maximum tolerated dose of topotecan hydrochloride combined with high-dose cyclophosphamide and carboplatin in the setting of autologous peripheral blood stem cell trans...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer
- Recurrent, relapsed, or persistent disease meeting 1 or more of the following criteria:
- Patients with a positive second-look laparotomy who are not candidates for higher priority GOG protocols
- Largest mass of recurrent disease ≤ 0.2 cm achieved by surgery or chemotherapy
- Achievement of complete response to 1 prior regimen of platinum-based chemotherapy with relapse \> 6 months from last chemotherapy
- Achievement of partial response to 1 platinum-based chemotherapy regimen prior to study
- Histological proof of disease recurrence with or without a rising serum CA-125 level (relapsed or recurrent disease)
- The following histological cell types are allowed:
- Clear-cell adenocarcinoma
- Endometrioid adenocarcinoma
- Mixed epithelial carcinoma
- Mucinous adenocarcinoma
- Serous adenocarcinoma
- Undifferentiated carcinoma
- Must have unilateral bone marrow aspirate and biopsy with cytogenetics without evidence of metastatic ovarian carcinoma by conventional morphology within 1 month of registration
- Not eligible for GOG-164
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Creatinine ≤ 1.5 mg/dL
- Total bilirubin ≤ 2.0 mg/dL (≤ 5.0 mg/dL with metastatic disease)
- AST ≤ 2 times upper limit of normal (ULN) (≤ 600 units/mL with metastatic disease)
- Alkaline phosphatase ≤ 2 times ULN (unless related to metastatic disease)
- ANC ≥ 1,000/mm\^3
- Platelets ≥ 100,000/mm\^3
- Cardiac ejection fraction ≥ 45% by rest ECHO or MUGA
- FEV\_1 ≥ 50% of predicted
- HIV negative
- No uncontrolled infection
- No severe medical or psychiatric illness, including any of the following:
- Renal failure
- Brittle insulin dependent diabetes mellitus
- Congestive heart failure
- History of myocardial infarction within the past 3 months
- Significant arrhythmia requiring medication
- Poorly controlled hypertension (diastolic blood pressure \>100 mm Hg)
- History of hospitalization for severe depression or psychosis
- Significant non-neoplastic pulmonary disease
- Current alcohol or drug abuse.
- Active infection
- Active peptic ulcer disease
- No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 1 prior treatment regimen for this cancer
- More than 3 weeks since surgery
- No prior topotecan hydrochloride
Exclusion
Key Trial Info
Start Date :
August 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 4 2016
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00652691
Start Date
August 1 1998
End Date
May 4 2016
Last Update
April 8 2019
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