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

Study Description

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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:

I. 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.

II. 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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	12 participants
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 :	November 1999
Actual Primary Completion Date :	February 6, 2002

Arms and Interventions

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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

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Overall survival [ Time Frame: Up to 11 years ]
2. PFS [ Time Frame: Up to 11 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

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Locations

United States, Pennsylvania
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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Gynecologic Oncology Group
ClinicalTrials.gov Identifier:	NCT00004221 History of Changes
Other Study ID Numbers:	GOG-9903; NCI-2012-02312 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); CDR0000067462; GOG-9903 ( Other Identifier: Gynecologic Oncology Group ); GOG-9903 ( Other Identifier: CTEP ); U10CA027469 ( U.S. NIH Grant/Contract )
First Posted:	August 25, 2003
Last Update Posted:	August 9, 2017
Last Verified:	August 2017

Additional relevant MeSH terms:

Carcinoma; Adenocarcinoma; Ovarian Neoplasms; Cystadenocarcinoma; Carcinoma, Endometrioid; Cystadenocarcinoma, Serous; Cystadenocarcinoma, Mucinous; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female	Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Cystic, Mucinous, and Serous; Endometrial Neoplasms; Uterine Neoplasms; Paclitaxel; Albumin-Bound Paclitaxel; Cyclophosphamide; Carboplatin; Topotecan; Lenograstim; Antineoplastic Agents, Phytogenic; Antineoplastic Agents