Know Cancer

or
forgot password

A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for Metastatic Adenocarcinoma of the Lower Esophagus, Gastroesophageal Junction, and Gastric Cardia


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

Thank you

Trial Information

A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for Metastatic Adenocarcinoma of the Lower Esophagus, Gastroesophageal Junction, and Gastric Cardia


OBJECTIVES:

Primary

- Determine the confirmed tumor response rate in patients with unresectable, metastatic
adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia treated
with bortezomib, paclitaxel, and carboplatin.

Secondary

- Determine the time to tumor progression, overall survival, and duration of response in
patients treated with this regimen.

- Determine the adverse events in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, and 8 and paclitaxel IV over 3
hours and carboplatin IV over 30 minutes on day 2. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months until disease
progression and then every 6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 17
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed adenocarcinoma of 1 of the following sites:

- Esophagus

- Gastroesophageal junction

- Gastric cardia

- No greater than 2 cm from the gastroesophageal junction into the stomach

- Unresectable, metastatic disease

- Not a candidate for potentially curative therapy AND no other more reasonable
potentially curative conventional therapy exists

- At least 1 measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by
spiral CT scan

- No known CNS metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin normal

- AST ≤ 3 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2 times ULN

Renal

- Creatinine ≤ 1.5 times ULN

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for up to 6 months after
completion of study treatment

- No peripheral neuropathy ≥ grade 2

- No uncontrolled infection

- No chronic debilitating disease

- No prior allergic reaction to carboplatin or paclitaxel

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior immunotherapy for recurrent or metastatic disease

- No prior biologic therapy for recurrent or metastatic disease

- No concurrent prophylactic colony-stimulating factors (filgrastim [G-CSF] or
sargramostim [GM-CSF])

Chemotherapy

- No prior chemotherapy for recurrent or metastatic disease

- Prior chemotherapy in the neoadjuvant or adjuvant setting (after complete resection
of the original tumor) allowed

- Prior combination chemotherapy and radiotherapy allowed provided patient achieved a
complete response AND the last dose of combination therapy was administered ≥ 6
months ago

Endocrine therapy

- Not specified

Radiotherapy

- See Chemotherapy

- No prior radiotherapy for recurrent or metastatic disease

- Prior radiotherapy in the neoadjuvant or adjuvant setting (after complete resection
of the original tumor) allowed

- No prior radiotherapy to > 25% of bone marrow for locally advanced disease

- More than 4 weeks since prior radiotherapy

Surgery

- More than 4 weeks since prior open abdominal exploration (e.g., laparotomy)

- More than 2 weeks since prior minimally invasive procedures (e.g., laparoscopy)

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirmed tumor response rate

Safety Issue:

No

Principal Investigator

Aminah Jatoi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000413896

NCT ID:

NCT00107341

Start Date:

August 2005

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • adenocarcinoma of the esophagus
  • stage IV esophageal cancer
  • recurrent esophageal cancer
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location