Radiation Therapy, Paclitaxel, and Cisplatin in Treating Patients With Cancer of the Cervix

NCT00003377 | Completed Phase 1 Results DMC

• 2 other identifiers: CDR0000066371GOG-9804
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 13

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel and cisplatin may increase the effectiveness of radiation therapy by making the tumor cells more sensitive to the radiation. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel when given with radiation therapy and cisplatin and to see how well they work in treating patients with cancer of the cervix that has spread to the lymph nodes in the pelvis and abdomen.

Conditions

Cervical Cancer

Keywords

stage III cervical cancer; stage IVA cervical cancer; cervical squamous cell carcinoma; cervical adenocarcinoma; cervical adenosquamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicity(DLT)/Significant Dose Delay of Paclitaxel With Cisplatin as Assessed by CTC 2.0 After 6 Cycles of Treatment

  up to 21 weeks

Secondary Outcomes (2)

• Disease-free Survival at 2 Years

  2 years

• Overall Survival at 2 Years

  2 years

Study Arms (1)

Radiation therapy plus concurrent weekly chemotherapy

OTHER

Drug: cisplatin; Drug: paclitaxel; Radiation: brachytherapy; Radiation: radiation therapy

Interventions

cisplatin DRUG

Radiation therapy plus concurrent weekly chemotherapy

paclitaxel DRUG

Radiation therapy plus concurrent weekly chemotherapy

brachytherapy RADIATION

Radiation therapy plus concurrent weekly chemotherapy

radiation therapy RADIATION

Radiation therapy plus concurrent weekly chemotherapy

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically proven previously untreated invasive carcinoma of the uterine cervix * Squamous cell carcinoma * Adenosquamous carcinoma * Adenocarcinoma * TNM classification stage IIIB or IVA (FIGO classification stage IB, IIA, IIB, IIIA, IIIB, or IVA) * Cytologically or histologically proven metastases to the para-aortic lymph nodes * No more than 8 weeks since diagnosis * No metastases to scalene nodes, intraperitoneal metastases, or metastases to other organs outside the radiation field at the time of original clinical and surgical staging * Negative CT scan of the chest * Patients with ureteral obstruction must be treated with stent or nephrostomy tube PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * GOG 0-2 Life expectancy: * At least 6 months Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times normal * SGOT no greater than 3 times normal Renal: * Creatinine less than 2.0 mg/dL * No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal transplantation) requiring modification of radiation fields Other: * Not pregnant * No septicemia or severe infection * No other invasive malignancy within the past 3 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior cytotoxic chemotherapy for this or other malignancy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for this or other malignancy * No prior radiotherapy to pelvis or abdomen Surgery: * Not specified Other: * No other prior therapy for this malignancy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (13)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242, United States

Location

Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees

Camden, New Jersey, 08103, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MetroHealth's Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic Cancer Center at Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, 43210, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Care Associates - Midtown Tulsa

Tulsa, Oklahoma, 74104, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Walker JL, Morrison A, DiSilvestro P, von Gruenigen VE; Gynecologic Oncology Group. A phase I/II study of extended field radiation therapy with concomitant paclitaxel and cisplatin chemotherapy in patients with cervical carcinoma metastatic to the para-aortic lymph nodes: a Gynecologic Oncology Group study. Gynecol Oncol. 2009 Jan;112(1):78-84. doi: 10.1016/j.ygyno.2008.09.035. Epub 2008 Nov 17.

  PMID: 19010522 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; Paclitaxel; Brachytherapy; Radiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics

Results Point of Contact

• Title: Melissa Leventhal
• Organization: Gynecologic Oncology Group Statistical & Data Center

mleventhal@gogstats.org

(716)845-5702

Study Officials

• Joan L. Walker, MD

  Oklahoma University Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: November 1, 1999
• First Posted: January 27, 2003
• Study Start: November 1, 1999
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: February 4, 2013
• Results First Posted: February 4, 2013

Record last verified: 2012-12

Locations

US (13)