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

NCT00550784 | Completed Phase 1

• 5 other identifiers: 00067P30CA033572CHNMC-00067CCC-PHI-31CDR0000567474
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; fallopian tube cancer; peritoneal cavity cancer

Outcome Measures

Primary Outcomes (7)

• Toxicity

• Tumor response

• Reason patient is removed from study

• Disease progression

• Overall survival

• Progression-free survival

• Time to progression

Interventions

filgrastim BIOLOGICAL

cisplatin DRUG

cyclophosphamide DRUG

melphalan DRUG

paclitaxel DRUG

topotecan hydrochloride DRUG

TdT-mediated dUTP nick end labeling assay GENETIC

gene expression analysis GENETIC

immunohistochemistry staining method OTHER

pharmacological study OTHER

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: Up to 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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 abdomen

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Filgrastim; Cisplatin; Cyclophosphamide; Melphalan; Paclitaxel; Topotecan; Gene Expression Profiling; Immunohistochemistry; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds; Genetic Techniques; Investigative Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Robert J. Morgan, MD

  City of Hope Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2007
• First Posted: October 30, 2007
• Study Start: January 1, 2001
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 7, 2014

Record last verified: 2014-10