A Trial for Patients With Advanced/Recurrent Cervical Cancer

NCT00190983 | Completed Phase 2 Results

• 2 other identifiers: 8367H3E-US-JMGS
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying the antitumor activity of single agent pemetrexed 900mg/m2 IV over 10 minutes in patients with recurrent cervical cancer.

Conditions

Cervical Intraepithelial Neoplasia; Uterine Neoplasms; Genital Neoplasms, Female

Outcome Measures

Primary Outcomes (1)

• Tumor Response

  Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

  baseline to measured progressive disease (up to 5 years)

Secondary Outcomes (3)

• Duration of Response

  time of initial response until documented tumor progression (up to 5 years)

• Progression-Free Survival

  baseline until documented tumor progression (up to 5 years)

• Overall Survival

  baseline until death from any cause (up to 5 years)

Study Arms (1)

Pemetrexed

EXPERIMENTAL

Drug: Pemetrexed

Interventions

Pemetrexed DRUG

Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression.

Pemetrexed

Eligibility Criteria

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

You may qualify if:

• Recurrent squamous or non-squamous cell carcinoma of the cervix with documented disease progression
• Measurable disease
• Gynecologic Oncology Group (GOG) performance status 0-2
• Patients must have received one prior systemic chemotherapy for persistent or recurrent disease
• Patients with mild to moderate renal insufficiency should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs\_ with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed.
• All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration.
• Folic Acid (350-1000 ug) must be given daily beginning approximately 5-7 days prior to first does of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy.
• Vitamin B12 (1000 ug) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy

You may not qualify if:

• Prior Pemetrexed
• Patients who have received radiation to more than 25% of marrow bearing areas
• Any evidence of other malignancy within last 5 years, with exception of non-melanoma skin cancer

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Gynecologic Oncology Group: collaborator

Study Sites (1)

Gynecologic Oncology Group 215-854-0770

Philadelphia, Pennsylvania, United States

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Neoplasms; Genital Neoplasms, Female

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

1-800-545-5979

Study Officials

• David Miller, MD

  Gynecologic Oncology Group

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: February 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: November 20, 2009
• Results First Posted: August 24, 2009

Record last verified: 2009-11

Locations

US (1)