Clinical trial · Interventional
Combination Chemotherapy and Autologous Peripheral Stem Cell Transplant in Treating Patients With Stage III, Stage IV, or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
Phase I Trial of Tandem Chemotherapy Cycles as Consolidation Therapy for High-Risk Epithelial Ovarian and Primary Peritoneal Cancer Utilizing Intraperitoneal Paclitaxel/IV Cyclophosphamide Followed by IV Topotecan/Intraperitoneal Cisplatin/IV Melphalan Using Hematopoietic Stem Cell Support
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Giving chemotherapy before a peripheral stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with cyclophosphamide, paclitaxel, melphalan, and cisplatin, followed by an autologous peripheral stem cell transplant in treating patients with stage III, stage IV, or recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cavity Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| gene expression analysis | Genetic | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (7)
- measure
- Toxicity
- measure
- Tumor response
- measure
- Reason patient is removed from study
- measure
- Disease progression
- measure
- Overall survival
- measure
- Progression-free survival
- measure
- Time to progression
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed ovarian epithelial carcinoma, primary peritoneal cavity carcinoma, or epithelial carcinoma of the fallopian tubes, meeting 1 of the following criteria:
* Stage III or IV disease that was treated with initial therapy comprising a standard platinum-containing regimen
* Must have \< 2 cm of residual disease with no evidence of disease progression after initial chemotherapy AND have no disease progression immediately prior to stem cell collection
* Patients initially presenting with stage IV disease who have achieved a clinical response (complete response \[CR\] or partial response \[PR\]) after initial therapy are eligible
* Responding recurrent disease
* Patients who have had recurrence with elevated CA 125 levels (\> 100 U/mL) and who have achieved a reduction of CA 125 level by 50% for 4 weeks following the most recent course of reinduction chemotherapy are eligible
* Patients who have achieved a CR or PR after salvage chemotherapy for relapsed disease are eligible
* Patients with measurable or evaluable disease must have achieved a PR after prior therapy
* No clinically significant pleural effusions
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* ANC \> 1,000/μL
* Platelet count \> 100,000/μL
* Serum bilirubin \< 1.5 mg/dL
* SGOT and SGPT ≤ 2.5 times normal
* Creatinine clearance ≥ 60 mL/min
* No active cardiac disease that, in the opinion of the investigator, would preclude safe administration of chemotherapy
* Cardiac ejection fraction normal at rest by MUGA
* No history of potentially disabling psychiatric disorders
* Hepatitis B antigen, hepatitis C antibody, and HIV antibody negative
* No clinically significant peripheral neuropathy
* FEV\_1 ≥ 2.0 L or ≥ 75% of the lower limit of normal
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy or radiotherapy
* No prior radiotherapy to the whole abdomenReferences
Publications (0)
Data not yet available