Know Cancer

or
forgot password

Phase I/II Trial Of Gemcitabine And ALIMTA In Patients With Measurable Or Evaluable, Unresectable Or Metastatic Biliary Tract Carcinoma (Intrahepatic, Extrahepatic, Ampulla Or Vater) And Gallbladder Carcinoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer

Thank you

Trial Information

Phase I/II Trial Of Gemcitabine And ALIMTA In Patients With Measurable Or Evaluable, Unresectable Or Metastatic Biliary Tract Carcinoma (Intrahepatic, Extrahepatic, Ampulla Or Vater) And Gallbladder Carcinoma


OBJECTIVES:

- Determine the maximum tolerated dose of gemcitabine when administered with pemetrexed
disodium in patients with unresectable or metastatic biliary tract or gallbladder
cancer. (Phase I closed to accrual as of Oct. 2005.)

- Determine the 6-month survival rate of patients treated with this regimen.

- Determine the best objective tumor response rate and duration of best objective tumor
response in patients treated with this regimen.

- Determine the time to progression and overall survival of patients treated with this
regimen.

- Determine the toxic effects of this regimen in these patients.

- Determine the individual patient variation in toxicity of and/or response to this
regimen due to genetic differences in proteins involved in drug response in these
patients.

OUTLINE: This is a multicenter phase I dose-escalation study of gemcitabine followed by a
phase II study.

- Phase I: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine IV
over 30 minutes on days 1 and 15. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity (phase I closed to accrual as of October
2005).

Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.

- Phase II: Patients receive pemetrexed disodium as in phase I and gemcitabine at the
recommended phase II dose.

Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- One of the following histologically or cytologically confirmed cancers not amenable
to treatment with combined chemotherapy and radiotherapy:

- Biliary tract (intrahepatic, extrahepatic, or ampulla of Vater) carcinoma

- Gallbladder carcinoma

- Unresectable or metastatic disease

- No CNS metastases

- Prior brain metastases treated with surgery or radiosurgery allowed provided
treatment was completed at least 4 weeks ago and there is no evidence of CNS
progression

- No clinically significant pericardial or pleural effusion or ascites unless able to
be drained before study entry

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 3 months

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 3 times upper limit of normal (ULN)

- AST no greater than 5 times ULN

Renal

- Creatinine no greater than 1.5 times ULN OR

- Creatinine clearance at least 45 mL/min

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer

- Able to tolerate folic acid, corticosteroids, or cyanocobalamin supplements

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 4 weeks since prior biologic or immunologic therapy

- No prior biologic or immunologic therapy for metastatic disease

- No concurrent immunotherapy

- No concurrent colony-stimulating factors during course 1

Chemotherapy

- No prior chemotherapy for metastatic disease

- No prior gemcitabine

- Prior chemoembolization allowed provided the following are true:

- At least 4 weeks since prior chemoembolization

- Evidence of new tumor growth since therapy

- At least 6 months since prior chemotherapy used as a radiosensitizer (in adjuvant
setting or for locally advanced disease)

- No other concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- Prior radiofrequency ablation allowed provided the following are true:

- At least 4 weeks since prior radiofrequency ablation

- Evidence of new tumor growth since therapy

- No prior radiotherapy to 25% or more of the bone marrow

- More than 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery

- Not specified

Other

- Prior embolization allowed provided the following are true:

- At least 4 weeks since prior embolization

- Evidence of new tumor growth since therapy

- No prior pemetrexed disodium

- No aspirin or nonsteroidal anti-inflammatory drugs for at least 2 days (5 days for
long-acting agents [e.g., piroxicam]) before, during, and for at least 2 days after
administration of pemetrexed disodium

- No concurrent cyclo-oxygenase-2 inhibitors

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Survival after 6 months of treatment

Safety Issue:

No

Principal Investigator

Steven R. Alberts, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000298862

NCT ID:

NCT00059865

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Liver Cancer
  • advanced adult primary liver cancer
  • unresectable gallbladder cancer
  • unresectable extrahepatic bile duct cancer
  • adult primary cholangiocellular carcinoma
  • Carcinoma
  • Liver Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms

Name

Location

CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Dickinson County Healthcare SystemIron Mountain, Michigan  49801
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Southwest Medical CenterLiberal, Kansas  67901
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
AnMed Cancer CenterAnderson, South Carolina  29621