Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia

NCT00017004 | Completed Phase 3

• 5 other identifiers: GOG-0191NCI-2012-02384CAN-NCIC-CX4CDR0000068641U10CA027469
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may stimulate red blood cell production to treat anemia in patients who have received chemotherapy and/or radiation therapy for cervical cancer. Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have cervical cancer.

Conditions

Anemia; Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma; Drug Toxicity; Radiation Toxicity; Stage IIB Cervical Cancer; Stage III Cervical Cancer; Stage IVA Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival with progression defined as a 50% or greater increase in the cross-product of the existing primary tumor relative to the smallest cross-product from all previous exams

  Up to 5 years

Secondary Outcomes (2)

• Overall survival

  Up to 5 years

• Local control, coded as successful if any relapse or disease progression is is contained within the pelvic field

  Up to 5 years

Study Arms (2)

Arm I

EXPERIMENTAL

Patients undergo radiotherapy comprising pelvic external beam radiotherapy daily five days a week for 5 weeks, followed by either 1 or 2 implants of low-dose rate intracavitary brachytherapy or 5 fractions of high-dose rate intracavitary brachytherapy, followed by 3-5 days of parametrial boost radiotherapy. Patients receive cisplatin IV concurrently with pelvic external beam radiotherapy on days 1, 8, 15, 22, 29, and once during the week of parametrial boost radiotherapy.

Radiation: External Beam Radiation Therapy; Drug: Cisplatin; Radiation: Internal Radiation Therapy

Arm II

EXPERIMENTAL

Patients undergo radiotherapy and chemotherapy as in arm I. Additionally, patients receive epoetin alfa subcutaneously once weekly concurrently with radiotherapy and chemotherapy.

Radiation: External Beam Radiation Therapy; Drug: Cisplatin; Radiation: Internal Radiation Therapy; Biological: Epoetin Alfa

Interventions

External Beam Radiation Therapy RADIATION

Undergo radiation

Also known as: Definitive Radiation Therapy, EBRT, External Beam RT

Arm I; Arm II

Cisplatin DRUG

Given IV

Arm I; Arm II

Internal Radiation Therapy RADIATION

Undergo radiation

Also known as: Brachytherapy, Internal Radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy

Arm I; Arm II

Epoetin Alfa BIOLOGICAL

Given SC

Also known as: EPO, Epogen, Eprex, erythropoietin, r-HuEPO

Arm II

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
• Stage IIB, IIIB, or IVA
• Primary, previously untreated disease
• Hemoglobin less than 14 g/dL at presentation
• Negative, non-suspicious para-aortic nodes determined by lymphangiogram, CT scan, MRI, or lymphadenectomy
• Eligible for treatment with radical intent involving concurrent cisplatin and pelvic radiotherapy
• No involvement of the lower third of vagina
• No carcinoma of the cervical stump
• Performance status - GOG 0-3
• See Disease Characteristics
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin no greater than 1.5 times normal
• SGOT no greater than 3 times normal
• Alkaline phosphatase no greater than 3 times normal

Sponsors & Collaborators

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

Study Sites (1)

Gynecologic Oncology Group of Arizona

Phoenix, Arizona, 85012, United States

Location

MeSH Terms

Conditions

Anemia; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Uterine Cervical Neoplasms

Interventions

Cisplatin; Brachytherapy; Epoetin Alfa; Erythropoietin

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Chemically-Induced Disorders; Wounds and Injuries; 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; Radiotherapy; Therapeutics; 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

• Gillian Thomas

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2001
• First Posted: January 27, 2003
• Study Start: August 1, 2001
• Primary Completion: May 15, 2004
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

US (1)