Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer

• Sponsor: Gynecologic Oncology Group (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00004221
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 12
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Ovarian Mixed Epithelial Tumor; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mucinous Cystadenocarcinoma; Ovarian Serous Cystadenocarcinoma; Primary Peritoneal Carcinoma; Stage III Ovarian Cancer; Undifferentiated Ovarian Carcinoma	Drug: Carboplatin; Drug: Cyclophosphamide; Biological: Filgrastim; Drug: Paclitaxel; Procedure: Peripheral Blood Stem Cell Transplantation; Drug: Topotecan Hydrochloride	Phase 2

Detailed Description

OBJECTIVES:

1. 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.

2. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Nov 1, 1999
• Actual Primary Completion Date: Feb 6, 2002

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Treatment (Combination chemotherapy, PBSC) See detailed description.

Drug: Carboplatin; Given IV; Other Names: Blastocarb Carboplat Carboplatin Hexal Carboplatino Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatinum Paraplat Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo ; Drug: Cyclophosphamide; Given IV; Other Names: (-)-Cyclophosphamide 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate Carloxan Ciclofosfamida Ciclofosfamide Cicloxal Clafen Claphene CP monohydrate CTX CYCLO-cell Cycloblastin Cycloblastine Cyclophospham Cyclophosphamid monohydrate Cyclophosphamidum Cyclophosphan Cyclophosphane Cyclophosphanum Cyclostin Cyclostine Cytophosphan Cytophosphane Cytoxan Fosfaseron Genoxal Genuxal Ledoxina Mitoxan Neosar Revimmune Syklofosfamid WR- 138719 ; Biological: Filgrastim; Given SQ; Other Names: Filgrastim XM02 G-CSF Neupogen r-metHuG-CSF Recombinant Methionyl Human Granulocyte Colony Stimulating Factor rG-CSF Tbo-filgrastim Tevagrastim ; Drug: Paclitaxel; Given IV; Other Names: Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat ; Procedure: Peripheral Blood Stem Cell Transplantation; Undergo autologous peripheral blood stem cell transplantation; Other Names: PBPC transplantation Peripheral Blood Progenitor Cell Transplantation Peripheral Stem Cell Support Peripheral Stem Cell Transplantation ; Drug: Topotecan Hydrochloride; Given IV; Other Names: Hycamptamine Hycamtin SKF S-104864-A Topotecan HCl topotecan hydrochloride (oral)

Outcome Measures

Primary Outcome Measures

1. Complete response defined as complete disappearance of all measurable and evaluable tumor documented at second-look surgery [Up to 11 years]

2. Indication of excessive toxicity defined as hospitalization > 14 days per course, delay of day 1 therapy > 14 days, or grade 3 (irreversible) or grade 4 vital organ toxicity (non-hematologic) [Up to 11 years]

Secondary Outcome Measures

1. Overall survival [Up to 11 years]

2. PFS [Up to 11 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gynecologic Oncology Group	Philadelphia	Pennsylvania	United States	19103

Sponsors and Collaborators

• Gynecologic Oncology Group
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Russell Schilder, Gynecologic Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gynecologic Oncology Group
• ClinicalTrials.gov Identifier: NCT00004221
• Other Study ID Numbers: GOG-9903; NCI-2012-02312; CDR0000067462; GOG-9903; GOG-9903; U10CA027469
• First Posted: Aug 25, 2003
• Last Update Posted: Aug 9, 2017
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Carcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Carcinoma, Endometrioid; Cystadenocarcinoma; Cystadenocarcinoma, Serous; Cystadenocarcinoma, Mucinous; Paclitaxel; Cyclophosphamide; Carboplatin; Albumin-Bound Paclitaxel; Topotecan; Lenograstim

Study Results

No Results Posted as of Aug 9, 2017