Paclitaxel, Cisplatin, and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer

NCT00002913 | Completed Phase 1

• 4 other identifiers: NCI-2012-02251GOG-9602U10CA027469CDR0000065286
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I trial to study the effectiveness of paclitaxel, cisplatin, and topotecan with or without filgrastim in treating patients who have newly diagnosed stage III or stage IV epithelial ovarian cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy

Conditions

Brenner Tumor; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mixed Epithelial Carcinoma; Ovarian Mucinous Cystadenocarcinoma; Ovarian Serous Cystadenocarcinoma; Ovarian Undifferentiated Adenocarcinoma; Stage III Ovarian Epithelial Cancer; Stage IV Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (1)

• Maximally tolerated doses (MTDs) of the combination of paclitaxel, Topotecan, and cisplatin administered without and with G-CSF based on dose-limiting toxicities (DLT) graded according to GOG Common Toxicity Criteria

  3 weeks

Secondary Outcomes (2)

• Overall survival

  Up to 10 years

• Progression-free survival

  Up to 10 years

Study Arms (1)

Treatment (paclitaxel, cisplatin, topotecan hydrochloride)

EXPERIMENTAL

Patients receive paclitaxel IV over 3 hours and cisplatin IV on day 1, followed by topotecan IV over 30 minutes on days 1-3. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 4-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

Drug: paclitaxel; Drug: cisplatin; Drug: topotecan hydrochloride; Biological: filgrastim

Interventions

paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol

Treatment (paclitaxel, cisplatin, topotecan hydrochloride)

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Treatment (paclitaxel, cisplatin, topotecan hydrochloride)

topotecan hydrochloride DRUG

Given IV

Also known as: hycamptamine, Hycamtin, SKF S-104864-A, TOPO

Treatment (paclitaxel, cisplatin, topotecan hydrochloride)

filgrastim BIOLOGICAL

Given SC

Also known as: G-CSF, Neupogen

Treatment (paclitaxel, cisplatin, topotecan hydrochloride)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed epithelial ovarian carcinoma
• No borderline ovarian carcinoma
• Stage III/IV disease that has been suboptimally or optimally debulked
• The following histologies are eligible:
• Adenocarcinoma (unspecified)
• Mucinous cystadenocarcinoma
• Clear cell adenocarcinoma
• Serous cystadenocarcinoma
• Endometrioid adenocarcinoma
• Transitional cell carcinoma
• Malignant Brenner's tumor
• Undifferentiated carcinoma
• Mixed epithelial carcinoma
• Extraovarian papillary serous cystadenocarcinoma
• Measurable or evaluable disease

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Gynecologic Oncology Group of Arizona

Phoenix, Arizona, 85012, United States

Location

MeSH Terms

Conditions

Brenner Tumor; Carcinoma, Ovarian Epithelial

Interventions

Paclitaxel; Taxes; Cisplatin; Topotecan; trioctyl phosphine oxide; Filgrastim; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian 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; Gonadal Disorders; Endocrine System Diseases; Carcinoma; Endocrine Gland Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Camptothecin; Alkaloids; Heterocyclic Compounds; 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

Study Officials

• Deborah Armstrong

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: December 1, 1996
• Primary Completion: July 1, 2007
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

US (1)