Intraperitoneal Paclitaxel, Doxorubicin Hydrochloride, and Cisplatin in Treating Patients With Stage III-IV Endometrial Cancer

NCT00575952 | Completed Phase 1

• 5 other identifiers: GOG-9920NCI-2009-00623CDR0000580419U10CA180868U10CA027469
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 9

Brief Summary

This phase I trial studies the side effects and best dose of intraperitoneal paclitaxel when given together with doxorubicin hydrochloride and cisplatin in treating patients with stage III-IV endometrial cancer. Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and cisplatin, 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

Endometrial Adenosquamous Carcinoma; Endometrial Clear Cell Adenocarcinoma; Endometrial Mixed Adenocarcinoma; Endometrial Serous Adenocarcinoma; Endometrial Squamous Cell Carcinoma; Endometrial Undifferentiated Carcinoma; Recurrent Uterine Corpus Carcinoma; Stage IIIA Uterine Corpus Cancer; Stage IIIC Uterine Corpus Cancer; Stage IVA Uterine Corpus Cancer; Stage IVB Uterine Corpus Cancer

Outcome Measures

Primary Outcomes (3)

• Incidence of observed DLTs, defined as grade 3-4 hematologic or non-hematologic toxicity graded using CTCAE v3.0

  18 weeks

• Maximum tolerated dose (MTD) of IP paclitaxel with fixed dose IV doxorubicin hydrochloride and IV cisplatin, determined according to dose-limiting toxicities (DLTs) graded using CTCAE v3.0

  12 weeks

• MTD of IP paclitaxel with fixed dose IV doxorubicin hydrochloride and IP cisplatin, determined according to DLTs graded using CTCAE v3.0

  12 weeks

Study Arms (1)

Treatment (doxorubicin hydrochloride, cisplatin, paclitaxel)

EXPERIMENTAL

Patients receive doxorubicin hydrochloride IV over 30 minutes followed by cisplatin IV over 1 hour on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive doxorubicin hydrochloride IV and cisplatin IV or IP on day 1, and paclitaxel IP on days 1 or 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Drug: Cisplatin; Drug: Doxorubicin Hydrochloride; Biological: Filgrastim; Drug: Paclitaxel; Biological: Pegfilgrastim

Interventions

Cisplatin DRUG

Given IV or IP

Treatment (doxorubicin hydrochloride, cisplatin, paclitaxel)

Doxorubicin Hydrochloride DRUG

Given IV

Treatment (doxorubicin hydrochloride, cisplatin, paclitaxel)

Filgrastim BIOLOGICAL

Given SC

Treatment (doxorubicin hydrochloride, cisplatin, paclitaxel)

Paclitaxel DRUG

Given IV or IP

Treatment (doxorubicin hydrochloride, cisplatin, paclitaxel)

Pegfilgrastim BIOLOGICAL

Given SC

Treatment (doxorubicin hydrochloride, cisplatin, paclitaxel)

Eligibility Criteria

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

You may qualify if:

• Patients with stage IIIA, or stage IIIC with positive cytologic washings/ascites, adnexal spread, or serosal involvement, or stage IV (by virtue of intraperitoneal disease spread) histologically confirmed endometrial cancer (endometrioid, serous, clear cell, squamous/adenosquamous, undifferentiated, or mixed histologies)
• Patients must be optimally cytoreduced with less than or equal to 2 cm residual disease
• Absolute neutrophil count (ANC) greater than or equal to 1,500/mm\^3, equivalent to Common Toxicity Criteria (Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0 \[v3.0\]) grade 1
• Platelets greater than or equal to 100,000/mm\^3 (CTCAE v3.0 grade 0-1)
• Hemoglobin greater than or equal to 10 g/dl (CTCAE v3.0 grade 1)
• Creatinine less than or equal to 2 mg/% or 24 hour creatinine clearance \> 50 ml/min
• Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (CTCAE v3.0 grade 1)
• Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1)
• Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1
• Patients must have normal ejection fraction
• Patients must be enrolled within 8 weeks of surgery
• Patients who have met the pre-entry requirements
• Patients must have signed an approved informed consent and authorization permitting release of personal health information
• Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

You may not qualify if:

• Metastatic disease involving lung or liver parenchyma, bone or inguinal or scalene lymph nodes
• Patients with GOG performance grade of 3 or 4
• Patients with concomitant medical illness such as serious uncontrolled infection, uncontrolled angina, or serious peripheral neuropathy, which in the opinion of the treating physician, makes the protocol prescribed treatments hazardous to the patient
• Patients with 3rd degree or complete heart block are not eligible unless a pacemaker is in place; patients who are on medications which alter cardiac conduction (digitalis, beta blockers, calcium channel blockers) or who have other cardiac conduction abnormalities may be placed on study at the discretion of the investigator
• Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
• Patients who have received prior radiation or chemotherapy for the cancer being treated in this study

Sponsors & Collaborators

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

Study Sites (9)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Interventions

Cisplatin; Doxorubicin; Filgrastim; Paclitaxel; pegfilgrastim

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• D. McMeekin

  NRG Oncology

  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 15, 2007
• First Posted: December 18, 2007
• Study Start: January 17, 2008
• Primary Completion: July 16, 2016
• Study Completion: July 16, 2016
• Last Updated: August 24, 2017

Record last verified: 2017-08

Locations

US (9)