A Trial for Patients With Advanced/Recurrent Cervical Cancer

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00190983
• Collaborator: Gynecologic Oncology Group (Other)
• Enrollment: 29
• Location: 1
• Arm: 1
• Duration (Months): 31.9
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Intraepithelial Neoplasia; Uterine Neoplasms; Genital Neoplasms, Female	Drug: Pemetrexed	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Evaluation of Pemetrexed (Alimta) in the Treatment of Recurrent Carcinoma of the Cervix
• Study Start Date: Feb 1, 2005
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Oct 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Tumor Response [baseline to measured progressive disease (up to 5 years)]

   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.

Secondary Outcome Measures

1. Duration of Response [time of initial response until documented tumor progression (up to 5 years)]

   The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.

2. Progression-Free Survival [baseline until documented tumor progression (up to 5 years)]

   The period from study entry until disease progression, death or date of last contact.

3. Overall Survival [baseline until death from any cause (up to 5 years)]

   Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gynecologic Oncology Group 215-854-0770	Philadelphia	Pennsylvania	United States

Sponsors and Collaborators

• Eli Lilly and Company
• Gynecologic Oncology Group

Investigators

• Study Chair: David Miller, MD, Gynecologic Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Lilly Clinical Trial Registry

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00190983
• Other Study ID Numbers: 8367; H3E-US-JMGS
• First Posted: Sep 19, 2005
• Last Update Posted: Nov 20, 2009
• Last Verified: Nov 1, 2009

• Additional relevant MeSH terms: Neoplasms; Cervical Intraepithelial Neoplasia; Uterine Neoplasms; Genital Neoplasms, Female; Pemetrexed

Study Results

Participant Flow

Arm/Group Title	Pemetrexed
Arm/Group Description	Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
Period Title: Overall Study
STARTED	29
COMPLETED	27
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Pemetrexed
Arm/Group Description	Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
Overall Participants	27
Age, Customized (participants) [Number]
<40 years	6 22.2%
40-49 years	9 33.3%
50-59 years	7 25.9%
60-69 years	4 14.8%
>69 years	1 3.7%
Sex: Female, Male (Count of Participants)
Female	27 100%
Male	0 0%
Race/Ethnicity, Customized (participants) [Number]
White	24 88.9%
Black	2 7.4%
Asian	1 3.7%
Region of Enrollment (participants) [Number]
United States	27 100%
Cell Type (participants) [Number]
Squamous	19 70.4%
Adenocarcinoma	6 22.2%
Clear cell	1 3.7%
Adenosquamous	1 3.7%
Gynecologic Oncology Group (GOG) Performance Status (participants) [Number]
0 - Fully active	16 59.3%
1 - Ambulatory, Restricted Strenuous Activity	9 33.3%
2 - Ambulatory, No Work Activities	2 7.4%
Prior Therapy (participants) [Number]
Prior Chemotherapy	27 100%
No Prior Chemotherapy	0 0%
Prior Radiotherapy	23 85.2%
No Prior Radiotherapy	4 14.8%
Tumor Grade (participants) [Number]
G1 - Well-Differentiated	5 18.5%
G2 - Moderately Differentiated	15 55.6%
G3 - Poorly Differentiated	5 18.5%
Unspecified	2 7.4%

Outcome Measures

1. Primary Outcome

Title	Tumor Response
Description	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.
Time Frame	baseline to measured progressive disease (up to 5 years)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pemetrexed
Arm/Group Description	Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
Measure Participants	27
Complete Response	0 0%
Partial Response	4 14.8%
Stable Disease	16 59.3%
Disease Progression	7 25.9%

2. Secondary Outcome

Title	Duration of Response
Description	The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Time Frame	time of initial response until documented tumor progression (up to 5 years)

Outcome Measure Data

Analysis Population Description

All enrolled participants who had either a complete response (n=0) or partial response (n=4).

Arm/Group Title	Pemetrexed
Arm/Group Description	Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
Measure Participants	4
Median (Full Range) [months]	4.4

3. Secondary Outcome

Title	Progression-Free Survival
Description	The period from study entry until disease progression, death or date of last contact.
Time Frame	baseline until documented tumor progression (up to 5 years)

Outcome Measure Data

Analysis Population Description

All enrolled participants who experienced disease progression.

Arm/Group Title	Pemetrexed
Arm/Group Description	Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
Measure Participants	7
Median (Full Range) [months]	3.1

4. Secondary Outcome

Title	Overall Survival
Description	Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Time Frame	baseline until death from any cause (up to 5 years)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pemetrexed
Arm/Group Description	Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
Measure Participants	27
Median (Full Range) [months]	7.4

Adverse Events

Arm/Group Title	Pemetrexed
Arm/Group Description	Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
All Cause Mortality
	Pemetrexed
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pemetrexed
	Affected / at Risk (%)	# Events
Total	5/ (NaN)
Blood and lymphatic system disorders
Febrile neutropenia	1/27 (3.7%)	1
Thrombocytopenia	1/27 (3.7%)	2
Gastrointestinal disorders
Gastrointestinal haemorrhage	1/27 (3.7%)	1
Infections and infestations
Pyelonephritis	1/27 (3.7%)	1
Investigations
Blood alkaline phosphatase increased	1/27 (3.7%)	1
Haemoglobin decreased	1/27 (3.7%)	1
White blood cell count decreased	1/27 (3.7%)	1
Metabolism and nutrition disorders
Hypoalbuminaemia	1/27 (3.7%)	1
Hypocalcaemia	1/27 (3.7%)	1
Reproductive system and breast disorders
Female genital tract fistula	1/27 (3.7%)	1
Other (Not Including Serious) Adverse Events
	Pemetrexed
	Affected / at Risk (%)	# Events
Total	27/ (NaN)
Blood and lymphatic system disorders
Anemia	23/27 (85.2%)
Leukopenia	19/27 (70.4%)
Lymphatics	4/27 (14.8%)
Neutropenia	17/27 (63%)
Thrombocytopenia	10/27 (37%)
Cardiac disorders
Cardiovascular	2/27 (7.4%)
Ear and labyrinth disorders
Auditory	2/27 (7.4%)
Eye disorders
Ocular	4/27 (14.8%)
Gastrointestinal disorders
Gastrointestinal	16/27 (59.3%)
Nausea/vomiting	13/27 (48.1%)
General disorders
Constitutional	21/27 (77.8%)
Pain	12/27 (44.4%)
Hepatobiliary disorders
Hepatic	5/27 (18.5%)
Infections and infestations
Infection	12/27 (44.4%)
Investigations
Alkaline phosphatase	11/27 (40.7%)
Serum glutamic oxaloacetic transaminase	4/27 (14.8%)
Metabolism and nutrition disorders
Metabolic	20/27 (74.1%)
Nervous system disorders
Neurotoxicity	8/27 (29.6%)
Respiratory, thoracic and mediastinal disorders
Pulmonary	3/27 (11.1%)
Skin and subcutaneous tissue disorders
Alopecia	4/27 (14.8%)
Dermatologic	11/27 (40.7%)
Vascular disorders
Hemorrhage	2/27 (7.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.