Topotecan, High-Dose Cyclophosphamide, Carboplatin, and an Autologous Peripheral Blood Cell Transplant in Treating Patients With Recurrent Ovarian Cancer or Primary Peritoneal Cancer

NCT00652691 | Completed Phase 1 DMC

• 3 other identifiers: 976101P30CA0150831056-98
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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 to prepare the bone marrow for the stem cell transplant. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This randomized trial is studying the side effects and best dose of topotecan when given together with high-dose cyclophosphamide, and carboplatin followed by an autologous peripheral blood stem cell transplant in treating patients with recurrent ovarian cancer or primary peritoneal cancer.

Conditions

Ovarian Cancer; Peritoneal Cavity Cancer

Keywords

peritoneal cavity cancer; ovarian clear cell tumor with proliferating activity; ovarian endometrioid adenocarcinoma; ovarian mixed epithelial carcinoma; recurrent ovarian epithelial cancer; ovarian mucinous cystadenocarcinoma; ovarian serous cystadenocarcinoma; ovarian undifferentiated adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose of topotecan hydrochloride

• Toxicity according to NCI criteria

Interventions

filgrastim BIOLOGICAL

carboplatin DRUG

cyclophosphamide DRUG

topotecan hydrochloride DRUG

autologous hematopoietic stem cell transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Related Publications (1)

• Litzow MR, Peethambaram PP, Safgren SL, Keeney GL, Ansell SM, Dispenzieri A, Elliott MA, Gastineau DA, Gertz MA, Inwards DJ, Lacy MQ, Micallef IN, Porrata LF, Lingle WL, Hartmann LC, Frost MH, Barrette BA, Long HJ, Suman VJ, Reid JM, Ames MM, Kaufmann SH. Phase I trial of autologous hematopoietic SCT with escalating doses of topotecan combined with CY and carboplatin in patients with relapsed or persistent ovarian or primary peritoneal carcinoma. Bone Marrow Transplant. 2010 Mar;45(3):490-7. doi: 10.1038/bmt.2009.181. Epub 2009 Aug 3.

  PMID: 19648970 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Filgrastim; Carboplatin; Cyclophosphamide; Topotecan; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital 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; Coordination Complexes; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Camptothecin; Alkaloids; Heterocyclic Compounds; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Mark R. Litzow, MD

  Mayo Clinic

  STUDY CHAIR

• Lawrence A Solberg, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 4, 2008
• Study Start: August 1, 1998
• Primary Completion: June 5, 2002
• Study Completion: May 4, 2016
• Last Updated: April 8, 2019

Record last verified: 2018-03