Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-11-30

Brief Summary

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There is no standard treatment for the patient population being asked to participate in this study. Although one current regimen, used by some investigators, has a high rate of response compared to other therapies, it is associated with moderate to severe toxicity. As gemcitabine and pemetrexed have a broad range of activity against cancer it is reasonable to determine how active and safe they are against patients with this type of cancer.The objective of this study is to determine the anti-tumor activity of pemetrexed and gemcitabine in patients with this condition.

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Detailed Description

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Conditions

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Adenocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pemetrexed

Intervention Type DRUG

Gemcitabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically proven adenocarcinoma
* No obvious primary on routine history, physical examination, and investigations
* Patients greater than or equal to 18 years of age
* ECOG Performance Status 0-1

Exclusion Criteria

* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Unable to stabilize pain and analgesics for a period of 7 days prior to starting study treatment
* Prior treatment with chemotherapy
* Bilirubin greater than or equal to 40 mol/L

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No