Cisplatin and Paclitaxel in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer

NCT00814086 | Completed Phase 1

• 4 other identifiers: GOG-9921NCI-2009-00624CDR0000629746U10CA027469
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 7

Brief Summary

This phase I trial is studying the side effects and best dose of cisplatin given together with paclitaxel in treating patients with stage IIB, stage IIC, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells.

Conditions

Chemotherapeutic Agent Toxicity; Endometrial Adenocarcinoma; Fallopian Tube Carcinoma; Gastrointestinal Complication; Malignant Ovarian Mixed Epithelial Tumor; Neurotoxicity Syndrome; Ovarian Brenner Tumor; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Mucinous Cystadenocarcinoma; Ovarian Serous Cystadenocarcinoma; Primary Peritoneal Carcinoma; Stage II Ovarian Cancer; Stage III Ovarian Cancer; Stage IV Ovarian Cancer; Undifferentiated Ovarian Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of patients who have at least 1 dose-limiting toxicity or delay in therapy for more than 2 weeks

  12 weeks

Secondary Outcomes (3)

• Grade of toxicity as assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)

  Up to 1 year

• Adverse events related to the catheter or the surgical placement of the catheter

  Up to 1 year

• Objective tumor response (partial or complete) assessed by Response Evaluation Criteria for Solid Tumors (RECIST)

  Up to 1 year

Study Arms (1)

Treatment (paclitaxel, cisplatin)

EXPERIMENTAL

Patients receive paclitaxel IV over 3 hours and cisplatin intraperitoneally (IP) on day 1 and paclitaxel IP on day 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: Paclitaxel; Drug: Cisplatin

Interventions

Paclitaxel DRUG

Given IV or intraperitoneally

Also known as: Anzatax, TAX

Treatment (paclitaxel, cisplatin)

Cisplatin DRUG

Given intraperitoneally

Treatment (paclitaxel, cisplatin)

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
• Stage IIB, IIC, III, or IV disease
• Optimal or suboptimal residual disease after debulking surgery within the past 12 weeks
• Appropriate tissue for histologic evaluation available
• The following histologic epithelial cell types are eligible:
• Serous adenocarcinoma
• Endometrioid adenocarcinoma
• Mucinous adenocarcinoma
• Undifferentiated carcinoma
• Clear cell adenocarcinoma
• Mixed epithelial carcinoma
• Transitional cell carcinoma
• Malignant Brenner tumor
• Adenocarcinoma not otherwise specified
• Carcinosarcoma

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Tulsa Cancer Institute

Tulsa, Oklahoma, 74146, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Neurotoxicity Syndromes; Brenner Tumor; Ovarian Neoplasms

Interventions

Paclitaxel; Taxes; Cisplatin

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; Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Gonadal Disorders; Endocrine System Diseases; Endocrine Gland Neoplasms

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

Study Officials

• Don Dizon

  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: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2008
• First Posted: December 23, 2008
• Study Start: February 1, 2009
• Primary Completion: July 1, 2011
• Last Updated: December 31, 2014

Record last verified: 2014-12

Locations

US (7)